Metrology Field Service Technician
PSC Biotech job in Pomona, CA
Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech , it's about more than just a job-it's about your career and your future.
Your Role
As a Metrology Field Service Technician, you will be the executor of measurement-focused on the precise, meticulous execution of validated procedures and the maintenance of environmental and equipment integrity. You will perform on‑site calibrations and validations for PSC Biotech and client facilities, serve as the point of contact while on‑site, and provide technical support and troubleshooting to ensure measurement validity and compliance.
Perform high‑accuracy calibration and functional testing in accordance with established procedures and applicable standards (e.g., ISO/IEC 17025: 7.1).
Strictly monitor and log laboratory and work‑area conditions (temperature, humidity, differential pressure, etc.) to maintain measurement validity.
Execute scheduled preventive maintenance and checks on primary/reference working standards and ancillary equipment; escalate out‑of‑tolerance conditions per approved procedures.
Perform on‑site calibrations, execute work orders, and complete service documentation with a high attention to detail and adherence to safety protocols.
Conduct on‑site validations and support projects as assigned, coordinating schedules and deliverables with project leads.
Manage and transport metrology equipment and standards for on‑site/project support in accordance with handling and chain‑of‑custody requirements.
Serve as the primary on‑site point of contact; interface with client end‑users and their internal support teams to plan, access, and execute scope safely and efficiently.
Perform calibrations independently, interpret results, and provide technical support and practical solutions to resolve issues.
Coordinate engagement meetings with clients on behalf of the Metrology Manager to align scope, timelines, and deliverables.
Perform troubleshooting and minor repairs within approved authority; document findings and recommend corrective actions.
Requirements
Bachelor's degree in Engineering, Metrology, Industrial Technology, Electronics, Life Sciences, or a related technical discipline is required.
4+ years experience performing calibrations using validated procedures on primary and reference standards in a GMP/GLP or ISO‑accredited environment.
Working knowledge of ISO/IEC 17025 principles, measurement traceability, and uncertainty.
Demonstrated ability to perform calibrations independently, troubleshoot instrumentation, and recommend technical solutions.
High attention to detail in measurement execution, data recording, and documentation accuracy.
Ability to strictly monitor and log environmental conditions (e.g., temperature, humidity) to ensure measurement validity.
Experience performing preventive maintenance and integrity checks on working standards and metrology equipment.
Experience interfacing directly with client end‑users, facilities personnel, and internal technical teams.
Capable of serving as the primary point of contact while on‑site and coordinating engagement discussions on behalf of the Metrology Manager.
Ability to work independently in a fast-paced environment.
Ability to travel to client sites across the U.S. to support project and calibration activities (travel percentage varies by assignment)
Must be authorized to work in the U.S.
No C2C at this time.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
Financial Perks and Discounts
Adhering to the requirements of California's law on pay transparency, the salary bracket for this role is set between $75,000 to $95,000. The offered rate can be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
#LI-RD1
Software Project Manager
PSC Biotech job in Los Angeles, CA
Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech , it's about more than just a job-it's about your career and your future.
Your Role
We are seeking a skilled and proactive Project Manager to lead the successful implementation of software solutions across the organization. This role involves managing project timelines, coordinating cross-functional teams, and ensuring that software deployments meet business requirements, quality standards, and deadlines.
Lead end-to-end software implementation projects, from planning through deployment and post-launch support.
Develop detailed project plans, including scope, schedule, budget, resources, and risk management strategies.
Collaborate with internal stakeholders, vendors, and technical teams to define project requirements and deliverables.
Monitor project progress and adjust plans as needed to ensure timely delivery.
Facilitate regular status meetings, provide updates to leadership, and manage stakeholder expectations.
Identify and mitigate project risks and issues proactively.
Ensure proper documentation, training, and change management processes are in place.
Evaluate project outcomes and conduct post-implementation reviews to identify areas for improvement.
Requirements
Bachelor's degree in computer science, Information Systems, Business, or related field.
3-5 years of experience managing software implementation projects.
Strong understanding of project management methodologies (Agile, Waterfall, Hybrid).
Experience with enterprise software systems (e.g., ERP, CRM, HRIS).
Excellent communication, leadership, and organizational skills.
Proficiency in project management tools (e.g., MS Project, Jira, Asana).
PMP, Scrum Master, or similar certification is a plus.
Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 to $110,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
#LI-RD1
Principal Production Planner
Irvine, CA job
We anticipate the application window for this opening will close on - 2 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
At Medtronic, we seek out and hire a diverse workforce at every level. We need fresh ideas and inclusive insights to continue being an innovative industry leader - that's why we make it a priority to seek, attract, and develop employees who are patient-centric, passionate, and who reflect the same wide range of life experiences as the patients we serve.
We are currently seeking a Principal Production Planner (Operations Planner) for our Irvine, CA site. This role sits within the Operations Scheduling organization and plays a critical, strategic role in ensuring supply continuity and operational excellence. The Principal Planner will collaborate extensively with Master Production Scheduling, Supply Network Planning, Engineering, Operations, Quality, Master Data, and external partners.
This position is fully on-site, with the expectation that the employee will be on campus for all working days. The ideal candidate has deep expertise in production planning, demonstrates strong leadership without formal authority, and brings thought leadership to drive supply chain improvements.
Do meaningful work, make a difference, and improve lives - starting with your own!
In this highly visible and influential role, you will drive end-to-end production planning execution and lead initiatives that improve supply health, operational efficiency, and delivery performance. You will own critical processes such as daily/weekly production scheduling, material readiness, new product introduction planning, and scenario analysis in support of key business objectives.
You will act as the primary planning expert for your value stream, identify and mitigate risks, influence cross-functional decisions, and provide insights that shape operational strategies.
**Responsibilities may include but are not limited to:**
+ Serve as the **primary planning authority** for the assigned value stream, providing strategic guidance and expert insights.
+ Own **production planning, prioritization, and KPI oversight** at a strategic level.
+ Lead **inventory management, consumption analysis** , and root-cause investigation for variances.
+ Develop and communicate **supply health assessments** , mitigation plans, and operational recommendations.
+ Conduct **scenario planning** , capacity analysis, and planning simulations to support business decisions.
+ Represent Operations Scheduling in cross-functional forums, presenting findings, risks, and recommendations.
+ Own and troubleshoot advanced master production scheduling issues within SAP, including master data impacts.
+ Partner with operations and supply chain leadership to define planning strategies that support financial and service goals.
+ Participate in and lead tier meetings, driving clarity and alignment on supply, materials availability, and production priorities.
+ Monitor and report performance metrics; develop insights to improve planning accuracy and operational execution.
+ Coach and provide guidance to less experienced planners (no direct people management required).
**Must Have:** **Minimum** **Requirements**
+ **Bachelor's degree**
+ **Minimum of 7 years of relevant experience** , OR
+ **Advanced degree with a minimum of 5 years of relevant experience**
**Nice to Have**
+ Deep experience with **MRP/ERP systems** (strong preference for SAP or Blue Yonder)
+ Advanced proficiency with **Microsoft Office** and data analysis tools
+ Strong analytical, quantitative, and data-driven decision-making skills
+ Excellent written and verbal communication skills; ability to influence peers and leadership
+ Strong organizational skills and mastery of cross-functional collaboration
+ Ability to identify patterns, connect detailed data to strategy, and anticipate upstream/downstream impacts
+ Experience working in a regulated industry (medical device or pharmaceutical preferred)
+ Understanding of quality systems and good manufacturing practices
+ **APICS CPIM/CSCP** or other supply chain certifications
+ Understanding of cost accounting principles
+ Knowledge of supply, services, or confidentiality contracts
+ Lean/Six Sigma Green Belt (or comparable continuous improvement training)
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$92,800.00 - $139,200.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (**************************************************************************************************************
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (************************* .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will...
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email *******************
To request removal of your personal information from our systems please email *****************************
Director, Field Medical Integrated Enablement & Engagement Process Lead (EPL)
Los Angeles, CA job
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
The Opportunity
The Director, Integrated Enablement & Engagement Process Lead (EPL) is a critical member of the Field Medical team, collaborating with the US Medical Digital team. This individual is instrumental in defining, aligning, and embedding digital, data, and analytics capabilities to not only meet current business needs but also proactively address and anticipate future needs. Acting as a key connector and central liaison between Field Medical and product teams, this role provides strong user understanding, workflow expertise, and product ecosystem knowledge to effectively embed tools within a complex, matrixed organization. Simultaneously, this role coordinates directly with users to drive successful user adoption of new digital capabilities and initiatives. This role plays a strategic part in identifying business needs, shaping product direction and prioritization, and integrating products into new and existing workflows to maximize impact in Field Medical. Furthermore, this role drives the planning and execution of change management, knowledge sharing, training, and adoption, as well as understanding and measurement activities, in partnership with Operational Excellence teams. This role requires a deep understanding of Field Medical priorities, standards of excellence, compliance, and the ability to intuitively manage, inspire, and build trust within a matrixed organization.
Key Responsibilities
* Strategic Liaison & Stakeholder Engagement: Serves as the primary point of contact for Field Medical capability needs, collaborating with cross-functional stakeholders to identify, synthesize, and prioritize user feedback, and ensuring end-to-end excellence across Field Medical digital and AI initiatives.
* Workflow Design & Process Integration: Accountable for seamless integration of new digital products into workflows, serving as a subject matter expert to identify capabilities, validate requirements, and lead process changes to optimize workflows.
* Enablement & Support: Develops and implements strategies to drive awareness and adoption of new tools, champions change management, and designs and delivers comprehensive training.
* Change Leadership & Continuous Improvement: Leads complex change initiatives, drives organizational change from current to future state, and continuously partners with stakeholders to ensure alignment on priorities.
* Measurement & Optimization: Regularly assesses and reports on the health of Field Medical operations, collaborates with partners to establish KPIs, and synthesizes measurement insights and user feedback into actionable learnings.
* Compliance & Governance: Establishes robust project governance frameworks, ensures adherence to regulatory compliance and privacy standards, and builds relationships with legal and compliance partners.
Who you are
Qualifications & Experience
* Bachelor's degree
* A minimum of 8 years of work experience, with at least 6 years of experience in the pharmaceutical or biotech industry, including 2 years in Healthcare Business Analytics.
* Experience in machine learning, deep learning, AI techniques, and building impactful data visualizations for medical decision-making (e.g., using Spotfire, Tableau, and RShiny). Strong data proficiency with a deep understanding of data strategy, technology, and platforms.
* Strong ability to work across functions in matrixed environments, providing strategic guidance, engaging stakeholders on data and visualization needs, and influencing senior leadership without direct authority.
* Experience with sole ownership of tactics or pieces, ability to articulate business problems, identify solutions, and own content development from strategy through execution. Demonstrated experience with strategic planning, prioritizing, and management of high-level initiatives and projects.
* Strong understanding of the healthcare landscape and customer types (health systems, payers, providers, HCPs, patients, IDNs, distributors, pathways), and how they operate their businesses.
Preferred Qualifications & Experience
* MBA or other related graduate-level degree
* 5+ years of experience in clinical development with strong skills in clinical trial data analysis, RWD assets.
* Six sigma, PMP, or similar certifications
* Proven ability to embed products, embrace agile methodologies, and effectively organize for impactful outcomes, while continuously investing in personal development.
* Demonstrates an enterprise and execution mindset, thriving in ambiguous, transformational environments with adaptive and critical thinking.
* Exhibits inspiring, visionary, customer-first leadership, strong business acumen, excellent presentation, interpersonal, and communication skills, alongside highly proficient project planning and oversight.
Location & Travel Requirements
The role is field-based, with a minimum of 30% of the time expected to be spent in the office in South San Francisco, CA, or traveling to locations designated by the Business.
The expected salary range for this position based on the primary location of South San Francisco, CA is $136,100 - 252,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Relocation benefits are not available for this job posting
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Senior Internal Auditor
Los Angeles, CA job
We anticipate the application window for this opening will close on - 30 Dec 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
**Internal Title:** Internal Audit Senior - Finance & Operations
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Medtronic's Diabetes Operating Unit serves over 500 million people globally, aiming to empower individuals with diabetes through meaningful innovation and personalized support. Their portfolio is designed to improve glucose control and reduce disease management time.
The business is undergoing a strategic IPO split, positioning itself as a high-growth, standalone company at the intersection of MedTech innovation and advanced manufacturing. With operations across North America, Europe, and Asia, the team is focused on delivering cutting-edge healthcare solutions with operational excellence. This transition offers a bold opportunity for the Diabetes team to operate with greater speed and agility, fostering future growth and innovation while reallocating resources across Medtronic.
We are seeking a motivated and detail-oriented **Finance and Operations Audit Senior** to join our **Internal Audit team** . This role offers the opportunity to support a growing audit function focused on Finance and Operations risk.
As an Audit Senior, you will assist in planning and executing audits, working closely with cross-functional teams to evaluate risks and strengthen internal controls. The ideal candidate will have strong analytical and communication skills, a proactive approach to problem-solving, and a desire to grow in a dynamic environment.
**This role requires you to work on-site at our Northridge, CA office at least 3 days per week.**
**Responsibilities:**
Responsibilities may include the following and other duties may be assigned.
+ Collaborate with cross-functional teams to evaluate risks and enhance internal controls.
+ Lead audit engagements, including SOX, audit and advisory to identify control gaps and recommend solutions. Ensure audit documentation is complete, accurate, and well-organized, reflecting a thorough understanding of the work performed and supporting conclusions.
+ Prepare reports and presentations that clearly communicate findings to senior leadership.
+ Support SOX scoping, testing of controls, and coordination with the external auditor.
+ Monitor open audit issues and ensure timely remediation.
+ Manage multiple projects independently, escalate issues promptly, and provide regular status updates to management.
+ Execute projects in accordance with policies, departmental procedures and International Standards for the Professional Practice of Internal Auditing.
+ Remain current with emerging trends, industry standards, and regulatory changes to proactively align audit strategies.
+ Contribute to continuous improvement and professional development initiatives.
**Must Have: Minimum Requirements**
EDUCATION/CERTIFICATION:
+ Bachelor's degree in accounting or finance.
+ Candidate must be certified CPA, MBA, CIA, or CMA
YEARS OF EXPERIENCE:
+ Bachelor's degree with a minimum of 4 years of audit, financial, or internal controls experience, **or** an advanced degree with a minimum of 2 years of practical experience in audit, financial, or internal controls experience.
SPECIALIZED KNOWLEDGE:
+ Public accounting (preferably Big 4) or equivalent experience in a public company Internal Audit department
+ Experience with accounting principles, audit procedures and techniques, and internal controls.
+ Understanding of SOX 404 requirements.
OTHER:
+ Must be fluent in English (written and spoken)
**Nice to Have**
+ Proficiency in using audit software and data analytics tools (e.g., AuditBoard, PowerBI)
+ Knowledge of industry standards and best practices (e.g., COSO)
+ Familiarity with financial systems (e.g., SAP, GRC, OneStream/Hyperion).
**Why Join Us?**
+ Shape the financial future of a newly independent public company.
+ Be part of a purpose-driven organization delivering breakthrough healthcare innovation.
+ Collaborate with a visionary executive team focused on long-term success and operational excellence.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$84,000.00 - $126,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (**************************************************************************************************************
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (************************* .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will...
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email *******************
To request removal of your personal information from our systems please email *****************************
Principal Aortic Clinical Specialist - Los Angeles, CA
Los Angeles, CA job
We anticipate the application window for this opening will close on - 5 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role.
**CAREERS THAT CHANGE LIVES -** **POSITION DESCRIPTION:**
The Principal Aortic Clinical Specialist provides technical, clinical, educational and sales support to ensure safe adoption and growth of the Medtronic Aortic technology. The Aortic Clinical Specialist works closely with physician implanting teams, the Medtronic Aortic Field Sales and Cardiovascular field organizations to drive procedural and practice success.
Technical and Clinical Support (50%)
+ Provide clinical expertise for Aortic implanting centers, including case sizing and planning, and providing technical support in accordance with the instructions for use, and best-practices to facilitate procedural consistency and best clinical outcomes.
Educational Support (35%)
+ Provide support for site performance and to facilitate procedural growth. Assist in education and training activities with physicians, hospital support staff and Medtronic personnel. Stay abreast of, and communicate, clinical data regarding Medtronic products and Aortic therapies.
Sales Support (15%)
+ Collaborate and strategize with territory sales representative and Aortic field organization in achieving sales targets and executing business plans.
**A DAY IN THE LIFE: POSITION RESPO** **NSIBILITIES:**
The following responsibilities are to be performed as appropriate in case support.
Technical and Clinical Support
+ Provide quality technical support to help sites achieve procedural success.
+ Provide technical support to Medtronic employees and implanting teams for Aortic implant procedures in accordance with Medtronic guidance.
+ Provide technical leadership for Aortic device procedures. Educate implanting teams on proper indications for Aortic procedures. Provide support on questions regarding device suitability with measuring ability and CT reconstruction expertise.
+ Provide comprehensive technical support including knowledge of imaging modalities (angiography/CT), wires and catheters, and ancillary procedural solutions.
+ Knowledge of Medtronic Aortic product IFUs for safe and effective use of devices.
+ Develop and maintain comprehensive clinical and technical product knowledge.
+ Understand current published Aortic and relevant literature.
+ Recognize and understand competitive products, industry trends, and Aortic/Peripheral portfolio. Liaison with Upstream Marketing for technology improvements and next generation needs.
Educational Support
+ Oversee local education and training activities including coordination and set up of procedure simulators, facilitation of simulated Aortic procedures and procedural troubleshooting, and coordination and facilitation of staff in-services to include pre/peri/post Aortic procedures.
+ Provide education on safe and effective use of Medtronic products.
+ Educate/train/In-service general surgery, vascular and cardio-thoracic fellows, and residents.
+ Ensure all vascular and cardio-thoracic fellows and residents are entered into the Aortic National Database.
+ Graduate all residents and fellows in SalesForce to ensure an appropriate handoff to the receiving territory.
Customer Service and Sales Support
+ Support district sales strategy working with sales representatives and managers to achieve business plans within the Aortic business. Contribute to the development of a strong team effort.
+ Ensure comprehensive technical and customer support within territory to maintain superior customer service levels and effective time management.
+ Shared responsibility of inventory management. To include customer management of inventory ordering, shelf stock, stagnant and returns. Ensuring there is no expired inventory in the field or implanted in a patient.
+ Identify, establish, and maintain productive working relationships with key decision makers, customers and their staff, administrative staff, etc.
+ Participate in customer/society education meetings and conventions where appropriate.
+ Respond to customer requests and resolve complaints in a prompt and effective manner.
+ Report device complaints within 48 hours through Medtronic mPXRin order to ensure proper reporting and compliance of device and procedural issues.
+ Help drive and maintain quality initiatives and global best practice initiatives.
+ Maintain high standards of personal presentation and promote a professional personal and company image.
Professional Development
+ Assist in training new hires to Medtronic Aortic team.
Administrative Responsibilities
+ Submit accurate and timely expense reports. All reports should be submitted every two weeks.
+ Maintain completion of all assigned Cornerstone trainings and assigned Allego trainings.
+ Schedule travel arrangements through Concur to ensure multiple objectives are accomplished.
+ Maintain hospital eligibility/access with various vendor credentialing services.
Communication
+ Maintain a high level of communication with appropriate Aortic sales and leadership within assigned geography.
+ Communicate market intelligence/competitor activity promptly, including potential sales leads, and information regarding product price or account activity to District Manager and other appropriate company personnel.
+ Always ensure a professional standard of written and verbal communication.
On-Call
+ Provide on-call case support for territories where needed. This includes week nights and weekends.
Travel
+ Travel within the region, area and nation may be required up to ≥50% of time.
+ Travel may require overnight stays.
**MUST HAVE -** **BASIC QUALIFICATIONS:**
_IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME_
High school diploma and 11 years' clinical or healthcare sales experience with at least 7 years' experience in the Vascular Industry, OR Associate Degree and 9 years' clinical or healthcare sales experience with at least 5 years' experience in the Vascular industry, OR Bachelor's degree and 7 years' clinical or healthcare sales experience with at least 3 years' experience in the Vascular industry
**NICE TO HAVE - DESIRED/PREFERRED QUALIFICATIONS:**
+ Associate's Degree in engineering, nursing, or the sciences.
+ Bachelor's Degree in Business or Science
+ Experience with wires, balloons, catheters, stents
+ Exceptional understanding of cardiac and vascular anatomy, physiology, and pathology
+ Experience communicating product's market advantages to physicians and hospital administration.
+ Experience managing multiple accounts.
+ Experience teaching and educating medical personnel, peers and technical support personnel
+ Imaging interpretation experience (CT, Angiograms)
+ Expertise with Microsoft Outlook, Excel, Word and PowerPoint
+ Excellent influencing and consulting skills
+ Excellent interpersonal and written communication skills
+ Ability to make timely and sound decisions
+ Strong project management skills with experience coordinating programs
+ Thorough working knowledge of medical terminology, medical proceduresand the medical device industry
+ Excellent customer service skills
+ Effectively build and maintain positive relationships with peers and colleagues across organizational levels and functions
+ Ability to coordinate/participate in numerous tasks/projects in a fast-paced environment in an organized manner while meeting deadlines
+ Excellent interpersonal, written and verbal communication skills
+ Strong work ethic in accomplishing objectives of the position
**PHYSICAL JOB REQUIREMENTS:**
+ The physical demands described within the Responsibilities section of this are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
+ While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers
+ Able to lift 20pounds
+ Extended periods of time doing computer-based work
+ Hearing, sight and speaking ability
+ Ability to use computers and CT reconstruction programing.
+ Ability to travel extensively by car and plane. Must have valid driver's license for state of residency and active vehicle insurance policy
+ Wear lead apron for long periods of time (2-3hrs on average)
+ Ability to operate a moving vehicle
+ Ability to work in Cath Labs or OR's with radiation exposure
+ Ability to travel with overnight stay up to 50-75% of the time (geography variability)
+ Ability to conduct company business outside of the typical Monday through Friday, 8:00am to 5:00pm, work-schedule
+ Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application
**ENVIRONMENTAL EXPOSURES:**
+ Infectious disease; radiation; blood borne pathogens
+ Must be able to wear all required personal protective equipment (PPE)
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$100,000.00 - $104,000.00
In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards here.
*****************************************************************************************************************************************************************************************************************************************************************
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (**************************************************************************************************************
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (************************* .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will...
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email *******************
To request removal of your personal information from our systems please email *****************************
Sr RF Test Engineer
Los Angeles, CA job
We anticipate the application window for this opening will close on - 7 Jan 2026
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeJoin the Medtronic Systems Engineering Test team bringing new products to market that help people living with diabetes more easily and successfully manage their diabetes. Patients, their loved ones, and their healthcare providers all take an active role in helping the patient managing their diabetes. New technologies and access to information are making things possible that open innovative and game changing systems possible. At Medtronic Diabetes, we work in the challenging space where medical devices are in the hands of everyday people and those people expect the state-of-the-art technology to help make things easier and more connected.
As an RF Test Engineer, you'll be in driving projects through the system Integration and product verification process using your solid engineering skillset, RF knowledge, energetic collaborative spirit, results driven work ethic, and solution facilitation skills. You will be supporting various Systems Engineering Test activities as integration, verification, trade studies, analysis, modeling, issue investigation & resolution, and documentation.
About - Diabetes Business Group
The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes, so people with diabetes can enjoy greater freedom and better health.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Responsibilities may include the following and other duties may be assigned.
Use existing and new tools and techniques to execute RF test cases to assess functional performance of devices
Design tools for performing RF integration and verification testing.
Participate in troubleshooting and triaging of issues with different teams to drive towards root cause identification and resolution.
Document, track and escalate issues as appropriate.
Develop test concepts and methods, create and analyze use cases and use conditions.
Plan, schedule, conduct, and monitor testing activities.
Develop, and review integration and verification strategies, test designs, test tools, planned execution and completeness of documentation.
Provide regular status to update the appropriate core teams and project leads
Minimum Requirements:
Bachelor's degree and a minimum of 4 years of relevant experience, OR Master's degree with a minimum of 2 years of relevant experience OR PhD with 0 years of relevant experience
Nice to Have:
Solid understanding of RF principals.
RF measurement background. Experience with RF equipment like Spectrum Analyzer, VNA, BLE Protocol Analyzer, etc.
Understanding of network protocols such as TCP/IP UDP
Familiar with RF stacks: BLE, WIFI, ZigBee, or ANT
Proficient on Python, C, or C#
Demonstrated analytical and problem-solving skills
Must be comfortable using command line tools.
Demonstrated experience generating technical documentation such as engineering reports, test plans & procedures
Excellent written and communication skills
Demonstrated experience in product development
Experience with development in a regulated industry such as medical device, defense, or automotive.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$103,200.00 - $154,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Auto-ApplyDirector, Retail Pharmacy and Trade Operations
Los Angeles, CA job
We anticipate the application window for this opening will close on - 5 Jan 2026
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeAt Medtronic Diabetes, we're transforming how patients access and experience care. We're seeking a Director of Retail Pharmacy and Trade Relations to lead our pharmacy and distribution strategy, forging partnerships that make life-changing technologies more accessible to people living with diabetes.
This role offers the opportunity to define the vision, build the strategy, and lead the team that will shape how Medtronic engages with pharmacies, wholesalers, and other trade partners-enhancing the patient experience and ensuring seamless access to our therapies. As patient expectations evolve, from convenience in fulfillment to high-touch clinical support, this leader will guide Medtronic's pharmacy value proposition today and into the future.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key Responsibilities
Establish the vision and strategic framework to deliver innovative, best-in-class distribution and patient access models.
Develop and implement Medtronic Diabetes' retail pharmacy strategy to strengthen patient connectivity and enhance the overall care experience.
Drive launch excellence in the trade channel by ensuring readiness across diverse stakeholders for both new product launches and in-market portfolio.
Partner with Market Access leadership to anticipate and address policy and payer changes impacting patient access.
In collaboration with IT, create data-driven dashboards and analytics tools to synthesize complex pharmacy data into actionable insights for decision-making, forecasting, and performance measurement.
Build and maintain strong cross-functional partnerships across commercial, finance, customer service, pharmacy operations, distribution, and market access.
Lead and expand Medtronic's external relationships with retail pharmacies, wholesalers, vendors, and other strategic trade partners.
Recruit, coach, and develop team members, fostering an inclusive culture of innovation, growth, and professional development.
Role Requirements:
Established relationships with wholesalers, retail chains, and independent pharmacies.
Demonstrated success as a contract negotiator and in managing complex partnerships.
Proven leadership of cross-functional teams and delivery of strategic initiatives.
Strong analytical, organizational, and project management skills.
Excellent communication and relationship-building abilities.
Positive, solutions-oriented, customer-first mindset.
Knowledge of U.S. pharmacy and trade regulations governing pharmaceuticals and medical devices.
5+ years dedicated to pharmacy services, trade operations, or related roles working for pharmaceutical or medical device company
Must Have Requirement:
Bachelor's degree and 10+ years of relevant experience with 7+ years of managerial experience
Or, advanced degree and 8+ years of relevant experience with 7+ years of managerial experience
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$164,000.00 - $246,000.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Auto-ApplySAP System Process Specialist (CVRM)
Los Angeles, CA job
ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).
The Opportunity
A System Process Specialist is being hired to participate in Greenfield Project execution and then support the facility after going live. The role will become member of SAP deployment team for Holly Springs and post go live become site first level support. Candidate will bring experience from one or more of following L4 business processes: EWM (Warehouse), Make, Plan, Asset, Quality
Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.
What You'll Do
A Systems Process Specialist acts in the 1-Stop-Shop and is part of the support, continuous improvement and onboarding and adoption value streams. The Systems Process Specialist has a profound process understanding and is collaborating with the Business Support Community to continuously improve business processes and underlying IT applications. By this, he/she acts as a trusted adviser of the end-user for any kind of inquiry as well as a bridge between the end user and other roles in the various support layers and can raise incidents on behalf of the user area or work with managers to train users . The role is specialist on a specific operation process area and is providing end-user support based on in-depth and long time professional experience in this domain. Examples of domains include Plan, Make, Quality, EWM (Warehouse), Assets etc. In projects the Systems Process Specialist can also represent the interests of the systems user group and has the responsibility of coordinating and bringing input from the area of responsibility to the project and communicating project goals, information and progress back to the business areas.
End User Operation Support
* Performs Level 1 On Site/Remote support and troubleshooting of applications, primarily focused on SAP R3 and ASPIRE but could expand to PI, MES, etc.
* Acts as Point of Contact for End User/business stakeholders in terms of business requests and IT related issues.
* Triages, prioritizes requests and tries to identify the nature / root cause of an issue (handling issue, data issue, authorization issue, IT issue).
* Distributes application issues and non-application issues that cannot be solved by him/her to the 2nd level and/or Global Team support.
* Coordinates end user groups and escalation management. Follows up on IT Service tickets to resolve issues in a timely manner. Supports issue clarification on request of 2nd level and/or Global Team support.
* Validates the resolution proposals and performs the necessary test in case tests are required.
* Cooperates with 2nd level and/or Global Team support during analysis of reported incidents.
* Maintains close coordination and communication with End User/site business stakeholders for major incidents.
* May be a role owner for local roles.
* Performs interface monitoring (business errors).
* Executes complex or critical system actions.
* For new IT initiatives/product/system roll out/Go Live to site, provides on site/remote on call support per business requirement such as adopting business shift pattern during initial roll out and stand down to remote On Call post Hyper Care after successful roll out.
* Supports Global/Enterprise and Local ITOT application/systems.
* Supports site audits and inspections, planned/unplanned events, and implementation of corrections, etc. as a Subject Matter Expert.
* Provides 24x7 routine operation service support per Service Level Agreements to business.
* Adheres to the requirements specified in IT related Roche's quality policies/quality standards or related SOP.
Continuous Improvement
* Supports/Leads Continuous Improvement opportunities related to ITOT applications/system.
* Regular exchange with the Support network and or BPMs on support cases, best practices and process improvement proposals with network relevance.
* Helps the End User to submit new ideas for process improvements, allowing a comprehensive approach for assessing both the process interdependencies as well impact to all underlying systems.
* Describes the full lifecycle of an integrated Change process to Business Process with System impact. This Framework combines the Assessment of the requirement, Build and Test work as well as Deployment and eventually delivery of the added value to the End User.
* Embodies PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.
Onboarding & Training
* Coordinates and conducts End User training.
* Supports user authorization workflows (e.g. request, verify training, approve).
* Adds information to the knowledge base.
* Creates/Reviews Knowledge Articles.
* Creates/Reviews training material.
* Initiates knowledge management process.
Who You Are
* Bachelor's degree in Informatics, Engineering, or equivalent.
* 5+ years of experience with SAP R3.
* Experience or familiarity with ASPIRE is a plus.
* Must have experience in biotech/pharmaceutical manufacturing GMP domain.
* Knowledgeable about integration with enterprise business systems (SAP, MES, LIMS, etc.) and data integrity concepts.
Soft Skills
* Strong analytical skills for effective troubleshooting and problem solving.
* Candidates must be self-driven and able to work well with others as a team member.
* Strong technical writing and verbal communication skills.
* Excellent customer service skills and delivery through agile mindset, stability, flexibility, and speed.
* Passion for learning and sharing/leveraging best practices.
* Eager to explore new technology and have the ability to learn new concepts.
Relocation Funding is not available for this role.
The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $80,500 - $149,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Regulatory Affairs Specialist II - Temporary
Irvine, CA job
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.
How You'll Make An Impact:
* Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity. Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the technical file. Each assigned technical file must be completed within a pre-defined timeline. Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work.
* Support the IVDR labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on the monthly manufacturing schedule,the product fill dates, the associated product lot numbers and change requests numbers. As needed, update labeling specifications to meet the IVDR requirements.
* Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document.
* Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world.
What You Bring:
* Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields
* 3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry.
* Knowledge of FDA, and CE marking requirements for IVD products is a plus
* Able to work independently and with others
* Communication skills, including negotiation and persuasion.
* Analytical, problem solving, computer, and critical thinking skills.
* Thorough knowledge of policies, practices and procedures related to RA.
Compensation: The estimated hourly range for this position is $45 to $50 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider.
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it.
Auto-ApplyInformation Security Governance, Risk & Compliance (GRC) Director
Los Angeles, CA job
We anticipate the application window for this opening will close on - 5 Jan 2026
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeThe Information Security Governance, Risk & Compliance (GRC) Director is responsible for leading and maturing the company's global security governance framework, enterprise cyber risk management program, and compliance activities across IT, OT, cloud, and regulated medical device environments. This leader ensures alignment with cybersecurity expectations, Quality System requirements, and industry best practices. The Director partners closely with IT, R&D, Operations, Legal/Privacy, Quality & Regulatory (QARA), and Internal Audit to strengthen the company's security posture, reduce enterprise risk, and ensure readiness for audits, inspections, and regulatory submissions.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Responsibilities may include the following and other duties may be assigned.
Governance & Security Program Management
Develop, manage, and continuously improve the Information Security Governance framework based on NIST 800-53, ISO 27001, and corporate risk objectives.
Establish and maintain enterprise security policies, standards, and procedures in coordination with QARA, Legal, and IT.
Lead the security steering committees and reporting for executive leadership and board-level governance.
Enterprise Cyber Risk Management
Own the global cyber risk management strategy, including frameworks, methodologies, risk assessments, and reporting.
Partner with business units, manufacturing sites, and R&D to identify, assess, and mitigate technology and cybersecurity risks.
Maintain the enterprise cyber risk register and report key risks, KRIs, and risk treatment plans to the CISO and leadership.
Lead risk assessments for new products, vendors, technologies, and manufacturing systems.
Regulatory & Compliance Oversight
Ensure ongoing compliance with SOX NIST 800-53, HIPAA, and global data protection laws.
Lead cybersecurity components of internal audits and third-party assessments.
Manage alignment with industry frameworks.
Controls Assurance & Audit Readiness
Build and operate a controls assurance program including internal control testing, continuous monitoring, and audit preparation.
Serve as the primary Information Security liaison to Internal Audit and Quality Audit
Develop and track remediation plans for audit findings, vulnerabilities, and nonconformities.
Vendor & Third-Party Security
Oversee third-party cybersecurity risk assessments, contract security language, and ongoing monitoring of suppliers, including global manufacturing partners.
Work with Procurement and Legal to ensure supply chain cyber requirements are enforced.
Team Leadership & Cross-Functional Collaboration
Lead, mentor, and develop a high-performing GRC team (policy, risk, audit, compliance, privacy alignment).
Communicate cyber risks and compliance status to executives in a clear, business-focused manner.
Required Knowledge and Experience:
Requires a Bachelors degree and minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience.
Nice to Have:
Bachelor's degree in Cybersecurity, Information Technology, Engineering, or related field.
10+ years of experience in information security, with at least 5 years in a GRC leadership role.
Deep understanding of NIST 800-53, NIST CSF, ISO 27001, and SOX
Experience leading enterprise risk assessments, control testing programs, and audit engagements.
Demonstrated success building and managing high-performance teams.
Excellent communication skills, including the ability to present complex security topics to executives and regulators.
Strong leadership presence and executive communication
Strategic and analytical mindset with a risk-based approach
Ability to influence cross-functionally in a regulated environment
Strong understanding of product, manufacturing, and enterprise cybersecurity
Continuous improvement and quality-driven mindset
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$176,800.00 - $265,200.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Auto-ApplyProduct Director, Marketing
Irvine, CA job
Innovation starts from the heart. Heart valve disease impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. Beyond raising awareness, our Marketing teams build lasting, trusted relationships with medical professionals and industry stakeholders to ensure patients can receive the treatments they need.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you'll make a difference:
* Own and develop marketing strategy, tactical development and content optimization for respective product or data initiative across the U.S.
* Manage and oversee the work of multiple areas, functionalities, scope and/or locations and may have financial budget responsibilities.
* Identify risk, develop and lead in the implementation of broad and more complex marketing strategies which may include negotiations with internal and external parties for multiple concurrent major products, campaigns, launches, programs, and initiatives
* Plan and direct complex marketing activities with large scale or significant business impact with the accountability for successful completion of all deliverables. Collaborate with cross functional and/or matrix teams for multiple concurrent major products, campaigns, launches, programs, and initiatives
* Direct line management responsibilities including a robust talent development plan in alignment with functional growth strategies and the desired culture of the department.
* Other incidental duties
What you'll need (Required):
Bachelor's Degree in in related field with experience in marketing and skill levels exceeding the requirements of the previous level or equivalent work experience based on Edwards's criteria Required and
Demonstrated track record in people management or equivalent work experience based on Edwards's criteria Required
Experience working in a regulated industry or equivalent work experience based on Edwards's criteria Preferred
Additional Skills:
* Travel up to 30%
* Proven successful project management leadership skills
* Proven expertise in Microsoft Office Suite and related tools and systems
* Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
* Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
* Demonstrated performance track record within relevant industry/function
* Expert understanding of related aspects of marketing concepts and principles while identifying applications of functional knowledge and existing methodologies to complex problems
* Expert understanding of market and competitive dynamics
* Expert knowledge of financial mechanism that relates to marketing including forecasting, expense budgeting and management, purchase order compliance and processing, and 3rd party vendor compliance management.
* Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including attracting, developing, and retaining talent and partnering with HR on all aspects of talent development
* Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of marketing to the business
* Expert understanding of marketing content approval processes and systems, regulatory guidelines and legal boundaries
* Strict attention to detail
* Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
* Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
* Ability to prioritize work within the team based on critical business needs
* Ability to articulate the vision of the business unit and function
* Demonstrated performance track record within relevant industry/function including talent management responsibilities
* Frequently interacts with customers, and internal and external management concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
* Lead briefings and technical meetings for internal and external representatives
* Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
* Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
* Provide leadership and direction to cross-functional teams to successfully implement systems, processes and related solutions
* Develop relationships and leverage them to influence change
* Support and solicit input from team members at all levels
* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $156,000 to $221,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Auto-ApplySenior Principal Automation Engineer (CVRM)
Los Angeles, CA job
** ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).
**The Opportunity**
A Senior Principal Automation Engineer is being hired to participate in Greenfield Project execution and then support the facility after going live.
Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.
Senior Principal Automation Engineer (Department: ITOT/Automation Engineering - Leadership Role) will be responsible for providing automation and instrumentation and controls engineering capabilities and experience to the ITOT / Automation Engineering Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup. Eventually focuses on providing long-term support for newly built facilities with respect to the automation and instrumentation and control systems for process, utility and building systems. Lead automation impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes. Be both a People Leader/ Coach and at times hands on SME.
**What You'll Do**
+ Provide automation, instrumentation, and control engineering design services for facility projects, including upgrades, capacity expansions, and equipment replacements..
+ Produce and review design drawings and specification documents (URS, FS, DS, etc.).
+ Support end-to-end system qualification, including test creation, execution, review and approval.
+ Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.
+ Review and approve vendor information packages, including drawings and specifications as directed to ensure user requirements are met.
+ Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.
+ Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes.
+ Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans).
+ Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.
+ Automation lead for equipment/software FAT, field testing and commissioning
+ Provide scope, qualification, resource, and budget estimates for automation impacting projects.
+ Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team.
+ Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices.
+ Provide input into network/global business processes and procedures (e.g. GSPs).
+ All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
+ Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt.
+ Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.
**Who You Are**
+ Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 7years experience.
+ Minimum of 8 years applicable automation and/or instrument and control system experience preferably majority in drug product function
+ 5 years in the pharmaceutical/biotech industry/GMP experience.
+ 24X7 on call support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required.
Knowledge, Skills and Abilities
+ Experience with Biopharmaceutical manufacturing, design or/and construction.
+ Knowledge of Industrial Ethernet networks for manufacturing.
+ Knowledge of vision systems
+ Knowledge of Drug Product Manufacturing processes including aseptic or robotic fillings systems, vial handling, environmental monitoring and clean utilities.
+ Knowledge of communication protocols for devices (OPC, Modbus, MQTT, Ethernet IO, IOT)
+ Knowledge of integration and data transfer with Level 2, 3, and 4 systems.
+ Qualification experience related to control and computer systems.
+ Ability to generate engineering drawings and specifications.
+ Knowledge of ISA standards and practices for instrumentation.
+ Knowledge of PID control theories and techniques.
+ Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred).
+ Practical knowledge of process automation systems, and associated programming languages (Rockwell and Siemens preferred).
+ Demonstrate strong organizational, communication, and interpersonal skills to effectively manage tasks and collaborate with diverse teams.
+ Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
+ Demonstrate strong working knowledge of PC based programs and web based systems.
+ Ability to work independently with no direct supervision.
+ Knowledge of GAMP5
+ Work in a standard office environment.
+ May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment.
+ May work with hazardous materials and chemicals.
**Relocation funding is available for this role.**
The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $114,400 - $212,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits (****************************************************
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Production/Chemical Dispensary Supervisor
Irvine, CA job
Bio-Rad is looking for a Production Chemical Dispensary Supervisor to supervise the Lineside/Warehousing Department and oversee a production team that distributes chemical raw materials used to produce liquid reagent products. This position plans and assigns work to direct labor personnel, implements policies and procedures, and recommends improvements in production methods, equipment, operating procedures and working conditions within established delivery, quality, compliance, safety, budget and cost standards.
How You'll Make An Impact:
* Manages a team of production associates engaged in receiving, staging, put away, cycle count, and scrapping of production chemical inventory.
* Work is monitored by the production manager.
* Supervises team according to established processes, techniques and policies.
* Schedules, assigns and manages the daily activities of a team.
* Monitors employee performance and prepares and communicates performance reviews.
* Coaches and trains personnel in their duties.
* Assists in the development of documentation procedures.
* Responsible for meeting key metrics such as production schedules, quality standards, production yields, cost targets.
* Monitors processes and makes adjustment to stay within schedule, budgets and established targets.
* Participate in a variety of standing meetings.
* Communicate priorities, performance results and objectives to team members.
* Troubleshoots production issues and escalates as appropriate.
* Participate on project teams as needed.
* Participate as the Bio-Rad representative for this department before FDA, DEA, CALOSHA, and other regulatory body audits.
* Make salary recommendations based upon individual performance.
* Interviews and select personnel.
What You Bring:
* High school diploma, GED or equivalent.
* Associate's degree or equivalent experience preferred.
* 3-5 years warehousing/logistics experience in a laboratory, instrument or chemical processing environment.
* 0-2 years production lead experience is a plus.
* Familiarity with assigned products.
* Proven analytical, communication, computer and some project management experience.
* Basic knowledge of inventory management, demand flow technology, production processes and related technologies.
* Relevant certifications or training a plus.
* Basic knowledge of regulatory requirements.
Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.
Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more!
Compensation: The estimated base salary range for this position is $68,640 - $92,900 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-KD2
Legal Entity: (USA_1000) Bio-Rad Laboratories, Inc.
Auto-ApplyCardiovascular Program Specialist - West Coast
Los Angeles, CA job
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, lets advance the world of minimally invasive care. Job Description Primary Function of Position The Cardiovascular Program Specialist (CVPS) will provide expert clinical support, education, and training to physicians, nurses, and hospital staff on the use of DaVinci cardiac surgery, devices and therapies. This role partners closely with the sales team, specifically the Cardiovascular Sales Manager (CVSM) to ensure safe and effective product adoption while driving positive patient outcomes. This role is part of a small team of strategic sales professionals across the country who are focused on developing cardiac surgeons, and all those associated with cardiac programs. Clinical Support & Case Coverage * Provide on-site case support in the operating room or hybrid OR for procedures involving robotic cardiac procedures and surgery technologies. * Serve as a clinical expert for product setup, troubleshooting, and optimal use during live cases. * Ensure compliance with clinical and safety protocols. * Expand the user base collaborating with CVSM to cultivate a training pipeline of new surgeons. * Exhibit proficiency in multiple technology platforms to effectively support DaVinci adoption of Multiport Single Port, digital solutions, and customer needs. * Promote advanced instruments and accessories to enhance surgical performance and promote surgeon autonomy. * Collaborate with cross-functional internal teams to identify and capitalize on opportunities for expanding the use of the da Vinci Surgical Systems and strengthening Intuitive's partnership with healthcare facilities. Training & Education * Conduct training for physicians and care team members on indications and proper use of robotic platforms. * Administer individualized surgeon and care team training sessions onsite and assist with organizing appropriate mentoring programs. * Support new site start-ups by delivering onboarding programs and in-services. * Act as a resource for ongoing education and product updates. * Design and implement tailored da Vinci pathways for surgeons and surgical teams to ensure proficient and autonomous system use, by providing recurring care team training as needed. * Maintain flexibility to support after-hours cases and provide weekend support as needed, dictated by the territory's adoption of robotic surgery. Collaboration & Sales Partnership * Partner with local ISI sales team, leadership, customer training, and business partners to execute the appropriate clinical plan for surgeons and surgical teams to ensure system autonomy within a reasonable time frame * Provide clinical insights to the commercial team to shape strategy and drive business growth. * Participate in physician education programs, workshops, and regional/national conferences. * Facilitate the adoption of our digital solutions through enhancing our customer infrastructure and capabilities. * Communicate and collaborate with ancillary equipment manufacturers to develop strategies to ensure overall programmatic success Market & Clinical Insights * Collect and communicate customer feedback to internal teams (sales, marketing, R&D). * Stay up to date on clinical literature, competitive products, and evolving treatment guidelines. * Assist in clinical trial support when required. Qualifications The Cardiovascular Program Specialist - West Coast must be based in a major West Coast city with convenient access to a major airport (e.g., Phoenix, Denver, Los Angeles, or Seattle). Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess to successfully perform in job) * Experience: 2+ years in a cardiac-related clinical role (electrophysiology, interventional cardiology, cardiac surgery, or critical care). * Previous physician assistant, surgical nurse PLUS industry experience is strongly preferred. Required Education and Training (As applicable - Specific education and training that an individual must possess to successfully perform in job) * Bachelor's degree required (preferably in science or business) * Education: Bachelor's degree in nursing, Life Sciences, or related field required. * Advanced degrees (RN, PA, NP, RT, or other clinical credentials) preferred. Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state "none") * None Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have) *
Deep understanding of cardiac anatomy, physiology, and interventional procedures. * Exhibit a working knowledge of typical hospital policies. * Excellent communication, teaching, and interpersonal skills. * Strong problem solving and troubleshooting skills. * Ability to work in high-pressure environments (OR/Cath lab) * Adaptability to evolving technologies and complex procedures. * Team oriented with a commercial mindset. * Willingness to travel up to 75% domestically. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.
Manager, Business Solutions THV
Los Angeles, CA job
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.
Aortic stenosis & aortic regurgitation impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
**How you will make an impact:**
+ Oversee the reengineering and optimization of business processes and systems using Power Platform. Act as a Power Platform Subject Matter Expert and be seen as a Power Platform specialist
+ Configure and test Power Platform systems (Power Apps, Power Automate) to execute features, integration, and reporting
+ Evaluate and validate functional business requirements against business needs. Translate the needs of the business into Power Platform and Dataverse solutions
+ Identify root causes and provide guidance for resolutions for testing and validation of Power Platform processes and systems
+ Serve as liaison between team members and stakeholders in the area of responsibility. Lead efforts to reengineer and optimize business processes and systems
+ Provide design and architecture guidance to project teams to execute tactical projects / initiatives
+ Provide leadership and guidance to business CRM administrators on best practices
+ Provide platform guidance to team members on CRM and Power Platform solutions
+ Identify and recommend innovations that significantly enhance efficiency and effectiveness of business processes
**What you will need (Required):**
+ Bachelor's Degree & a minimum of 8 years of experience in a digital Project Management, Product Management or Customer Success role OR equivalent related experience based on Edwards criteria
+ A minimum of 3 years hands-on experience with Power Apps (Canvas and Model-driven applications)
+ A minimum of 3 years experience with Power Automate (Cloud flows, Desktop flows, Business process flows)
+ A minimum of 2 years experience with Microsoft Dataverse (data modeling, security, business rules)
**What else we look for (Preferred):**
+ Stay current with latest platform features
+ Microsoft Power Platform certifications (PL-200, PL-400 preferred)
+ Proven successful project management skills
+ Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
+ Extensive knowledge in at least discipline (e.g. Power Platform ALM and solution management)
+ Substantial technical knowledge with expertise in at least one technical language or data management system (e.g. Knowledge of Power BI for embedded analytics within Power Apps)
+ Extensive knowledge of platform ecosystem and integration points within Power Platform and governance
+ Represents leadership on sections of projects within a specific area interfacing with project managers and team. Ability to train and mentor team members on Power Platform best practices
+ Consult in project setting within specific sections of area (Experience integrating Power Platform with Azure services and Microsoft 365)
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $118,000 - $167,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
\#LI-Hybrid
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**COVID Vaccination Requirement**
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Robotics Automation Engineer
PSC Biotech job in Los Angeles, CA
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech , it's about more than just a job-it's about your career and your future.
Your Role
As a Robotics Engineer supporting pharmaceutical manufacturing programs, you will play a key role in designing, developing, integrating, and validating robotic systems used in the preparation and handling of drug‑related components. You will collaborate with cross‑functional engineering, quality, and manufacturing teams to ensure that all robotic solutions meet stringent regulatory expectations and operate safely, reliably, and compliantly in GxP‑regulated environments.
Design, model, and prototype robotic mechanisms, actuators, and motion systems appropriate for aseptic and controlled environments.
Develop control algorithms, sensor integrations, and automation logic for precise robotic manipulation and handling tasks.
Lead system integration activities, ensuring seamless coordination between mechanical, electrical, software, and control system components.
Perform risk assessments (FMEA, hazard analyses) aligned with pharmaceutical quality and safety expectations.
Support commissioning, qualification, and validation (IQ/OQ/PQ‑aligned testing methodology) of robotic systems in accordance with internal quality systems and regulatory guidelines.
Develop engineering documentation, including CAD models, technical specifications, test protocols, validation deliverables, and traceability records.
Collaborate with Quality, Manufacturing, R&D, and Automation teams to troubleshoot issues, optimize performance, and maintain ongoing system reliability.
Provide technical support for maintenance planning, lifecycle management, and continuous improvement efforts.
Ensure all robotic systems comply with FDA, EU, and global GxP expectations related to data integrity, safety, and product quality.
Requirements
Bachelor's degree in Robotics Engineering, Mechanical Engineering, Mechatronics, Electrical Engineering, or related discipline (advanced degree preferred).
7+ years experience designing, integrating, or validating robotic or electromechanical systems-preferably in a regulated environment (pharma, medical device, biotech, or advanced manufacturing).
Proficiency with CAD tools (SolidWorks, Creo, or similar) and experience with motion control, actuators, and sensor integration.
Familiarity with programming languages used in robotics (Python, C++, MATLAB, ROS, PLC logic, etc.).
Experience contributing to structured validation or testing activities (e.g., system verification, protocol execution, structured acceptance testing).
Strong understanding of risk analysis, system safety, and reliability engineering.
Excellent communication skills and the ability to work cross‑functionally in multidisciplinary engineering teams.
Must be authorized to work in the U.S.
No C2C at this time.
BenefitsOffering a full suite of benefits, PSC Biotech⢠is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $130,000 - $150,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
#LI -RT1
Validation Engineer
PSC Biotech job in Irvine, CA
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech , it's about more than just a job-it's about your career and your future.
Your Role
Our Validation Engineers support the full CQV lifecycle, ensuring facilities, utilities, equipment, computerized systems, and manufacturing processes are designed, installed, operated, and maintained in compliance with FDA, EU, and global GxP regulations. This role plays a critical part in reducing compliance risks and enhancing operational performance while executing high -quality validation deliverables, providing technical expertise, and supporting regulatory readiness.
Responsible for the planning, commissioning, qualification, and validation activities for required cGMP manufacturing and lab equipment, utilities, and computerized systems.
Author, review, and execute validation deliverables including but not limited to validation plans, design specifications, user requirement specifications, risk assessments, DQ, IQ, OQ, PQ generation and testing, summary and final reporting.
Perform system readiness assessments and verification testing.
Ensure systems meet user requirements, functional specifications, and data integrity expectations.
Manage system implementation activities including configuration, backup/restore, and periodic reviews.
Write, review, and approve SOPs; ensure documentation is accurate, traceable, audit -ready, and compliant.
Participate in deviation investigations, root cause analysis, and support CAPA implementation and change control processes.
Provide user training and ongoing technical support.
Collaborate with cross -functional teams to align on technical functions, deliverables, and quality events.
Additional responsibilities as required to drive project success.
Requirements
Bachelor's degree in engineering or related technical discipline.
3-10 years of experience in validation within GMP -regulated environments (pharmaceutical or biotech).
Hands -on experience validating GxP manufacturing and lab based equipment, analytical instruments, and associated computerized systems.
Strong understanding of full lifecycle validation and risk -based approach.
Well -versed in regulatory requirements and guidelines (FDA, EMA, ICH, cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11).
Experienced with traceability, change control, deviation handling, and CAPA management.
Strong technical writing and documentation skills.
Excellent attention to detail, problem -solving, and analytical skills.
Ability to manage multiple projects and timelines.
Willingness to travel as needed for project assignments and client engagements.
Must be authorized to work in the US.
No C2C at this time.
BenefitsOffering a full suite of benefits, PSC Biotech⢠is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $75,000 - $125,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
#LI -RD1
Senior Principal IT/OT Infrastructure Engineer (CVRM)
Los Angeles, CA job
ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).
The Opportunity
A Senior Principal ITOT Infrastructure Engineer is being hired to participate in Greenfield Project execution and then support the facility after going live.
Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.
What You'll Do
Senior Principal ITOT Infrastructure Engineer (Department: ITOT/Infrastructure - Leadership Role) will be Responsible for providing IT Infrastructure engineering capabilities and experience to the ITOT Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup focussed on data center and filed IT infrastructure. Eventually focuses on providing long-term support for newly built facilities with respect to the Infrastructure for process, utility and building systems. Lead Infrastructure impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes. Be both a People Leader/ Coach and at times hands on SME. Act as Cyber Security Coordinator / Engineer. Provide basic IT support for Site workplace needs in collaboration with Global IT groups.
* Site Owner of "OT Infrastructure" for Manufacturing System Platforms including Syncade MES, DeltaV Distributed Control System, PLC's, Lab Data Systems (Smartline Data Cockpit)
* Site Lead for Global Cyber Security Initiatives
* Site OT Infrastructure Support Lead and Coordinator with Global Infrastructure solutions at site (e.g. support of AD and firewall policies to allow proper access and communication from either AD security or network firewall policies, and commissioning and startup support)
* May eventually expand role to become Regional OT Infrastructure Lead for multiple sites supporting ITOT operating model evolution
* Collaborate with IT Engineers and Architects, Automation Engineers
* Lead and/or provide support for the evaluation, installation, and maintenance of Manufacturing infrastructure including installation and upgrade of control systems hardware, software, control networks, user administration, database administration, security, system monitoring, backup and recovery of Microsoft Windows Server Operating Systems and SQL Databases
* Lead and/or support implementation of OT infrastructure standards and best practices across all Site OT and Process Automation platforms, working with other process automation engineers, IT and OT professionals.
* Support commissioning and startup activity of new process control systems and manufacturing systems (Syncade, DeltaV, PLC's, OSI PI historian, etc).
* Be the go to Infrastructure expert at the site who bridges the gap between Automation and underlying Storage Compute and Network infrastructure
* Execute control system virtualization administration, user administration, system monitoring, capacity planning, design, installation, configuration, and upgrade of platform.
* Execute computer system validation and control system lifecycle management.
* Produce and review design drawings and specification documents (URS, FS, DS, etc.).
* Support end-to-end system qualification, including test creation, execution, review and approval.
* Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.
* Review and approve vendor information packages, including drawings and specifications as directed to ensure user requirements are met.
* Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.
* Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes.
* Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans).
* Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.
* Automation lead for equipment/software FAT, field testing and commissioning
* Provide scope, qualification, resource, and budget estimates for automation impacting projects.
* Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team.
* Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices.
* Provide input into network/global business processes and procedures (e.g. GSPs).
* All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
* Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt.
* Support work of the Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.
Who You Are
* Bachelor's degree in Engineering, Computer Science, or equivalent experience.
* A minimum of 5 years systems engineer experience involved in the design, implementation, and/or support of automation systems, preferably in a regulated (Pharmaceutical) industry.
* 24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required.
* Experience with Operating Systems, Virtualization, LAN/WAN, Firewalls, SQL Servers client-server and terminal virtualization as a System Administrator
* Certifications: Certified Information System Security Professional (CISSP), ISA/IEC 62443 Cybersecurity Specialist certification, Global Industrial Cyber Security Professional (GICSP) is a plus
Knowledge, Skills and Abilities
* Experience with Biopharmaceutical manufacturing, design or/and construction.
* Knowledge of Industrial Ethernet networks for manufacturing.
* Knowledge of vision systems
* Knowledge of Drug Product Manufacturing processes including aseptic or robotic fillings systems, vial handling, environmental monitoring and clean utilities.
* Knowledge of communication protocols for devices (OPC, Modbus, MQTT, Ethernet IO, IOT)
* Knowledge of integration and data transfer with Level 2, 3, and 4 systems.
* Qualification experience related to control and computer systems.
* Ability to generate engineering drawings and specifications.
* Demonstrate strong organizational, communication, and interpersonal skills to effectively manage tasks and collaborate with diverse teams.
* Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
* Demonstrate strong working knowledge of PC based programs and web based systems.
* Ability to work independently with no direct supervision.
* Knowledge of GAMP5
* Work in a standard office environment.
* May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment.
* May work with hazardous materials and chemicals.
Relocation funding is available for this role.
The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $114,400 - $212,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
CQV Project Manager
PSC Biotech job in Los Angeles, CA
At PSC Biotech, we provide the life sciences industry with expert engineering, technical, and consulting services that drive operational excellence, ensure regulatory compliance, and enhance productivity. Your Role
Our CQV Project Managers deliver comprehensive support to clients throughout every stage of the CQV lifecycle. They offer expert guidance in project planning, strategic development, and execution, employing a risk -based methodology to ensure adherence to regulatory standards and the highest levels of product safety.
Requirements
Bachelor's degree in related engineering discipline.
5+ years of experience managing end -to -end CQV activities for capital projects, including URS development, FAT/SAT execution, and validation documentation for GMP -compliant pharmaceutical production environments
Experienced managing full CQV lifecycle projects. Highly skilled in project planning and scheduling, budget management, risk mitigation, stakeholder communication, and vendor/contractor coordination.
Well -veresed in CQV risk based approach.
Expertise in industry regulations, requirements, and guidelines.
Proven success in project planning, initiation, execution, and closure.
Strong attention to detail and commitment to quality and compliance.
Strong problem solving and analytical skills.
Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Must be authorized to work in the US.
No C2C at this time.
Benefits
Offering a full suite of benefits, PSC Biotech⢠is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $120,000 to $165,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement:
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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