Quality Engineer jobs at BioFire Diagnostics

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. Agilent Technologies Nucleic Acids Solutions Division is looking to for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: * Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. * Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. * Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. * Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. * Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. * Provide work product updates to clients and project teams in the form of slides, memos and reports. * Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. * Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications * Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field * Knowledge and 8+ experience in a GMP API setting. * Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. * Knowledge and experience in process validation studies at the bench and in a plant setting. * Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable #LI-TH1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 17, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit ********************************* Travel Required: No Shift: Day Duration: No End Date Job Function: R&D

The Quality Manager provides a critical leadership role within National Jewish Health managing the development and implementation of comprehensive quality and safety programs across the continuum of care within the NJH institution and services. This position ensures the development, implementation, and evaluation of quality related policies, practices, and programs and is accountable for the management and implementation of quality programs including reporting of quality and patient safety metrics, reporting of clinical and outcome data, regulatory compliance and education and training on best practices. Essential Duties Manages and develops an effective staff: providing effective communication, leadership, guidance and resources. Determines staff qualifications and competency: recruits, interviews, selects, hires, trains, orients, mentors, evaluates, coaches, counsels, disciplines, and rewards. Establishes and monitors staff safety and regulatory compliance. Ensures implementation, maintenance and evaluation of efficient, integrated, hospital-wide, quality improvement, regulatory readiness, and patient safety programs, engaging stakeholders of all types to improve organizational performance and using evidence-based practice based on available data. Functions as a resource for leadership and medical staff in regards to improving hospital performance. Provides leadership for and reporting of board, leadership, medical staff, nursing, and employees in planning, design, implementation, and maintenance of systems that enable the hospital to meet new and/or mandated regulations related to quality, public reporting, CMS and others. Coordinates and monitors efforts of various departments related to compliance with mandated regulations such as never events. Develops and maintains dashboards for ongoing monitoring of quality and patient safety. Coordinates Patient Safety activities with Risk Management activities including data collection, analysis, reporting, improvement activities and follow-up related to quality and patient safety adverse events. Oversees Patient Advocates and complaints and grievances process. Ensures peer review completed for sentinel and adverse events. Develops annual patient safety plan and key performance indicators for the Board Quality Committee and the Operating Plan. Reviews and utilizes information from internal and external reporting programs. Participates in the development of performance metrics internally and as requested by external agencies. Develops and maintains a mechanism for internal and external communication of quality and patient safety related information. Reports to the governing body the hospital's performance on key quality indicators that include patient safety, clinical excellence, patient satisfaction, regulatory readiness, etc. Competencies Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health. Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures. Business Acumen: Using economic, financial, market, and industry data to understand and improve business results; using one's understanding of major business functions, industry trends, and own organization's position to contribute to effective business strategies and tactics. Collaboration/Teamwork: Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others. Managing Work and Time/Project Management: Effectively managing one's time and resources to ensure that work is completed efficiently. Effectively manages project(s) by appropriately focusing attention on the critical few priorities; effectively creates and executes against project timelines based on priorities, resource availability, and other project requirements (i.e., budget); effectively evaluates planned approaches, determines feasibility, and makes adjustments when needed. Peer Relationships: Interacts with others in a constructive, positive, and respectful manner, regardless of individual differences. Assists team members or co-workers in achieving personal goals and completing assignments. Talent Management for Leaders: Clearly establishes and communicates expectations and accountabilities; monitors and evaluates performance; provides effective feedback and coaching; identifies development needs and helps employees address them to achieve optimal performance. Supervisory or Managerial Responsibility Manages 1-10 employees Travel None Core Values Be available to work as scheduled and report to work on time. Be willing to accept supervision and work well with others. Be well groomed, appropriately for your role and wear ID Badge visibly. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually. Promotes a workplace culture based on mutual respect and merit, where all individuals are treated fairly and provided with equal opportunity to contribute to the mission and goals of the institution. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures. Wears appropriate PPE as outlined by the infection control policies and procedures. Demonstrates compliance with all state, federal and all other regulatory agency requirements. Minimum Qualifications Education: Bachelor's degree in a health-care-related field or science is required. Work Experience: A minimum of 5 years of recent and relevant experience in the QI/PI or medical field required and 1 year of leadership experience required. Special Training, Certification or Licensure: National Quality and Safety Certifications are preferred. Salary Range: $102,589.71 - $135,674.89 Benefits At National Jewish Health, we recognize that our outstanding faculty and staff are the essence of our organization. For every aspect of health care, our employees are our greatest asset. With that in mind, we have designed a valuable, comprehensive benefits package to meet the needs of our employees and their families. Comprehensive Medical Coverage: Multiple Cigna health plans for Colorado, regional office and remote employees. Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) available to pair with some plans. Paid Time Off: Generous PTO accruals to use for vacation and sick days, and six paid holidays, all compliant with Colorado state sick leave regulations. Dental & Vision Plans: Coverage effective the first of the month after hire. Retirement Savings: 403(b) plan with employer contributions after two years. Wellness Incentives: Earn up to $200 annually for preventive health activities. Tuition Reimbursement: Up to $5,250 annually for full-time and part-time employees. Child Care Assistance: Childcare Flex Spending Account (FSA) with annual employer contribution. Loan Forgiveness: Public Service Loan Forgiveness (PSLF) eligible employer. Disability & Life Insurance: Employer-paid plans and optional buy-up choices. Voluntary Benefits: Full suite of coverage options such as Accident, Hospital Indemnity and Legal Plan Exclusive Discounts: Savings on local services, insurance, and RTD bus passes. Anticipated Application Deadline: 2025-10-17

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. Agilent Technologies Nucleic Acids Solutions Division is looking to for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. Provide work product updates to clients and project teams in the form of slides, memos and reports. Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field Knowledge and 8+ experience in a GMP API setting. Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. Knowledge and experience in process validation studies at the bench and in a plant setting. Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable #LI-TH1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 17, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit *************************************** Required: NoShift: DayDuration: No End DateJob Function: R&D

We anticipate the application window for this opening will close on - 31 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** Responsibilities may include the following and other duties may be assigned. + Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. + Collaborates with engineering and manufacturing functions to ensure quality standards are in place. + Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. + Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. + Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. + May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. **TECHNICAL SPECIALIST CAREER STREAM:** An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills. **DIFFERENTIATING FACTORS** **Autonomy:** Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists. **Organizational Impact:** Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area. **Innovation and Complexity:** Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. **Communication and Influence:** Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making. **Leadership and Talent Management:** Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. **Required Knowledge and Experience:** Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant 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):$119,200.00 - $178,800.00 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 *****************************

We anticipate the application window for this opening will close on - 31 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** We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle. Develop and maintain comprehensive strategies for risk management activities, including: + Creating and managing risk management plans and reports, as well as conducting regular risk reviews. + Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures. + Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts. + Analyzing and reviewing product complaints to anticipate and prevent future issues. + Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed. + Implementing and maintaining robust product security measures to protect against potential vulnerabilities. + Developing and managing post-market surveillance plans to monitor product performance and safety in the field. + Maintaining and curating risk logs to ensure accurate and up-to-date risk documentation Other potential responsibilities + Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. + Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle. + Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. + Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements. + Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports. **Qualifications:** **Minimum Requirements:** + **Education:** Bachelor's degree in Engineering, or a related technical field. Advanced degree preferred. + **Regulatory Knowledge:** In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards. + **Problem-Solving:** Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis. + **Communication:** Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders. + **Leadership:** Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously. **Preferred Qualifications:** + **Certifications:** Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred. + **Experience:** Experience in Quality Assurance, Engineering, Capital equipment + **Industry Experience:** Medical device industry. + **Technical Skills:** Proficient in quality assurance practices, risk management, and regulatory compliance. **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):$119,200.00 - $178,800.00 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 *****************************

We anticipate the application window for this opening will close on - 31 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 We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle. Develop and maintain comprehensive strategies for risk management activities, including: * Creating and managing risk management plans and reports, as well as conducting regular risk reviews. * Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures. * Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts. * Analyzing and reviewing product complaints to anticipate and prevent future issues. * Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed. * Implementing and maintaining robust product security measures to protect against potential vulnerabilities. * Developing and managing post-market surveillance plans to monitor product performance and safety in the field. * Maintaining and curating risk logs to ensure accurate and up-to-date risk documentation Other potential responsibilities * Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. * Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle. * Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. * Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements. * Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports. Qualifications: Minimum Requirements: * Education: Bachelor's degree in Engineering, or a related technical field. Advanced degree preferred. * Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards. * Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis. * Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders. * Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously. Preferred Qualifications: * Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred. * Experience: Experience in Quality Assurance, Engineering, Capital equipment * Industry Experience: Medical device industry. * Technical Skills: Proficient in quality assurance practices, risk management, and regulatory compliance. 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):$119,200.00 - $178,800.00 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 anticipate the application window for this opening will close on - 31 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 Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant 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):$119,200.00 - $178,800.00This 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.

Clinical Quality Specialist 150 top places to work in healthcare|2025 Becker's Hospital Review Benefits: Here at Gunnison Valley Health, your good work will be rewarded. In addition to a competitive salary, a generous and affordable medical/dental/vision plan, up to 3%, there are other great perks including: Up to $250 in your first year toward your unique Lifestyle Spending Account, matched retirement starting on day 1, and a dependent care matching plan A culture that values continuing education, backed up by a robust tuition reimbursement plan, and an all-access subscription to LinkedIn Learning and Headspace. Paid time off benefits with an accrual rate of 10.77% in your first year of employment Access to mental health, financial health and wellness as well as life coaching with our Employee Assistance Program Free nutrition consultations, and discounted fitness membership at Western Colorado University Fieldhouse Deep discounts on food and drink in the cafeteria No traffic, and a scenic commute to the office Share your talents in providing compassionate and high quality patient care in a specialty clinic setting, ensuring the well-being and comfort of patients while supporting the clinic's mission and goals. We need your expertise to keep our community healthy and thriving! Where you'll live: Some define happiness by their job title and salary, while others pursue quality of life. Our community combines the best of both worlds by fostering a growing outdoor industry business hub in the heart of Colorado's Rocky Mountains. The Gunnison Valley, which includes the towns of Gunnison and Crested Butte, is a vibrant community of entrepreneurs and adventurers. We are deeply connected with our surrounding environment, neighbors and growing community. This is the kind of place where hard work is rewarded, whether that means a day on the mountain or at the office. Requirements: To be seriously considered for this role, you'll need to have: Education: Nursing Degree Required Experience: Minimum of three years of clinical experience in a healthcare setting required Licenses/Certification: Active RN or other clinical license preferred Responsibilities: We are committed to improving the health of our community by delivering exceptional care and services. As part of this team you will: Play a critical role in supporting performance improvement, patient safety, regulatory readiness, reporting, and data-informed decision-making throughout the organization. Guided by the National Association for Healthcare Quality's (NAHQ) eight-domain Healthcare Quality Competency Framework, the Clinical Quality Specialist helps drive sustainable, system-level improvements across our rural Critical Access Hospital health system. Leverage the organization's analytic environment to help guide data-driven decision making and inform quality improvement initiatives Cultivate a safe healthcare environment by promoting safe practices, nurturing a just culture, and improving processes that detect, mitigate, or prevent harm Direct organization-wide processes for evaluating, monitoring, and improving compliance with internal and external requirements. Leads the organization's processes to prepare for, participate in, and follow up on regulatory, accreditation, and certification surveys and activities Engage in the healthcare quality profession with a commitment to practicing ethically, enhancing one's competence, and advancing the field. Physical Requirements: Occasionally (1-33%) Pushing/pulling (20-50 lbs) Frequently (34-66%) Standing, walking, sitting, change position, reach, reach across midline, handling, crouching/squatting, stooping, stairs, lifting (0-20 lbs), carrying (0-20 lbs) Continuously (37-100%) Must be able to see with corrective eyewear, must be able to hear clearly with assistance Compensation: $26.64 - $33.30/hr, depending on experience. Your total compensation goes beyond the number on your paycheck. Gunnison Valley Health provides generous leave, health plans and retirement contributions that add to your bottom line. There is no deadline to apply for this position; we are accepting applications on an ongoing basis until a finalist is selected. Benefits Eligibility Medical, dental, vision, health care FSA, dependent care FSA, and Lifestyle Spending Account: All active employees working 40 or more hours per pay period in a Full Time or Part Time position are eligible for benefits on the first of the month after hire. Full Time staff are automatically enrolled in 401A plan as of date of hire. Life and AD&D insurance: All active employees working 40 or more hours per pay period are eligible for benefits on the first of the month after hire date. Short-term and long-term disability: All active employees working 60 or more hours per pay period are eligible for benefits on the first of the month after hire date.

As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: * Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. * Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. * Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. * Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Support the design and execution of Design of Experiments (DOE) and Validated Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. * Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. * Provide work product updates to clients and project teams in the form of slides, memos and reports. * Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. * Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field. * 4+ years relevant experience and/or training; or equivalent combination of education and experience. * 3+ experience in a GMP API setting. * Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. * Knowledge and experience in process validation studies at the bench and in a plant setting. * Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable. Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least November 26, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $87,600.00 - $136,875.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit ********************************* Travel Required: No Shift: Day Duration: No End Date Job Function: R&D

Job TitleAdvanced Manufacturing Engineer 1Job Description In this role you will drive and deliver innovation within the area of process development for new product introduction; ensure that manufacturing processes are capable, scalable, and stable against specifications and requirements; and identify and recommend solutions for complex technical issues in a regulated environment. Your role: Initiating and partnering with AME teammates in the development of processes within the phases of a PDLM (Product Design & Lifecyle Management) of new medical device products. Be an essential cross-functional teammate in initiating and delivering on product industrialization activities, including equipment selection, process automation, process characterization, and process validation. Align and represent the team in areas DFx. With a focus on design for manufacturability, reliability, serviceability, and test. Driving and making data-driven decisions on key performance indicators such as cost of goods (COGS), yield, output, quality throughout projects, and into commercialization Develop your technical career by becoming a subject matter expert in your work, and put your engineering skills to the test in complex problem-solving. You're the right fit if: You've acquired 4+ years of experience with a vocational education in such areas as manufacturing/operations environment, engineering, industrial engineering, system engineering, production engineering, or cost engineering. No prior experience needed with a Bachelor's degree in the above areas Your skills include a breadth of knowledge in manufacturing production processes and experience in how changes to existing products impact cost, performance, quality, and throughput; experience in process development and continuous improvement with a focus on automation, a data-driven mindset with a background in statistical tools. Preferred skills: experience in manufacturing and continuous improvement with an ISO 13485 or other regulated environment and familiarity with Test Method Validations (TMV), IQ/OQ/PQ You have a bachelor's degree or vocational education in mechanical engineering, electronics engineering sciences, cost engineering, manufacturing engineering, lean engineering or industrial automation You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You're passionate about delivering innovative technical solutions in a manufacturing team-based environment, you're self-motivated but able to build a network and learn quickly from others, recognize problems and take corrective action when appropriate; familiarity with working on complex issues with cross-functional team members to achieve effective resolution, and communicating needs and progress to stakeholders How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in Colorado is $67,500 to $108,000 The actual base pay offered may vary within the posted ranges depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Colorado Springs, CO. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Duties and Responsibilities: Effectively strategize and execute with all levels of the organization around concepts of design controls, process controls/validation; supplier controls, failure investigation and root cause analysis, inspection/test methods, sampling/statistical techniques, corrective and preventive actions, and risk management. Product Development: Provide quality engineering strategic support to product development activities, including design verification and validation, test method development and validation, and general design control activities to assure submission-worthy objective evidence generation. Notified body primary contact for significant change notifications, certification maintenance, dossier review Process Validation/ Monitoring: Collaborate with Operations Team in process validation and monitoring strategy, including IQ/ OQ/ PQ, Test Method Validation, Gage R&R. Author organizational Quality Plans. Implement and monitor product and process quality using statistically based techniques. Risk Management: Lead product and process risk assessment activities: FMEA and Risk Management Reports. Supplier Quality: Lead supplier qualification activities including conducting supplier audits. Manage the Supplier Performance Program. Interface with suppliers to address non-conformances and drive timely corrective actions. Audits and Inspections: Lead preparation and inspection management activities. Establish front & back room protocol, audit roles, etc. Coach organization to a sustainable state of constant inspection readiness. Customer Complaints: Manage the customer complaint handling process, including performing failure investigations and root cause analysis. Corrective and Preventive Actions: Manage the CAPA program, including identification of quality issues/trends, perform or lead root cause analysis activities, identify, manage and/or lead corrective/preventive actions, oversee CAPA implementation and assess effectiveness. Internal Audit: Manage the internal audit program, including hosting internal audits, performing internal audits, and driving resolution of internal audit corrective action activities. General: Provide technical leadership, coaching and strategic guidance to the Quality team in the areas of inspection/test activities, calibration, cleanroom certification and monitoring, and sterilization validation. Lead and manage quality system improvement projects and overall QMS suitability. Qualifications Education & Certifications: BS in Engineering, Science, Biomedical or related field of study. CQE certification preferred. ISO 13485 Lead Auditor certification strongly preferred. Work Experience: 12+ years of Quality leadership experience within the medical technology domain. Experience in the manufacture of sterile disposable products a must. Experience with intravascular devices a plus. Combination product experience highly preferred. Knowledge, Skills & Abilities: Knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485), risk management (ISO 14971), biocompatibility (ISO 10993-1), ethylene oxide sterilization (ISO 11135), sterile product packaging (ISO 11607), product microbial monitoring (ISO 11737) and cleanroom monitoring (ISO 14644). Experience with building and conducting QMS Management Review Direct experience with notified body and health authority interactions Experience with medical device complaint handling/investigation and related post-market health authority inquiries Experience with eQMS migration/implementation/validation Knowledge and application of statistical techniques, SPC, DOE, and problem-solving tools. Strong influence leadership and cross-functional, consensus building experience Adept in use of computer software for the analysis of data, such as Microsoft Excel and Minitab. Must possess a strong sense of urgency, teamwork, keen attention to detail, ability to plan, organize and multi-task. Excellent communication skills (oral and written). Physical Requirements: N/A

"What's it like to work at Agilent in Manufacturing? Watch the video" Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** Want to take your knowledge and experience further? Ready to provide technical leadership and make key decisions? This is your opportunity - not only to join a committed, professional, and forward-thinking team but also to lead in the design and implementation of complex manufacturing processes and transform broad concepts into structured results-focused projects. Join a growing team with this exciting new opportunity for an Process Engineer at our Boulder, Colorado GMP facility. Work in our dynamic, fast-paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics. Responsibilities may include but are not limited to: Provide project/process engineering support of a GMP manufacturing process (Upstream, Midstream, Downstream, Utilities). Responsible for any area of focus with the existing manufacturing process. Area of focus will also be supported during projects. Supporting small to large sized capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design integration, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing. Participate with project management through coordination of multi-disciplinary teams. Collaborate with Chemical Development and Manufacturing Services groups with activities such as technical transfer and scale-up of processes into manufacturing. Collaborate and facilitate project EHS activities including Process Hazard Analysis, Safety Checklist, and PSM compliance to meet OSHA standards. Ensure for all projects a high level of cGMP compliance to meet the ICH requirements for pharmaceutical buildouts. Support Validation activities including review of Factory Acceptance Test and Site Acceptance Test (FAT/SAT) protocols and participating in FAT/SAT execution, review of installation, operational, and performance qualification (IQ/OQ/PQ) protocols, participating in IOPQ execution, and review of final reports. Support regulatory activities including writing, review, and/or resolution of Change Controls (CC/CSC), Corrective and Preventive Actions (CAPAs), and audit responses. Integrate with Manufacturing and Quality Assurance groups with day-to-day troubleshooting and maintenance activities for projects/process, through identification of process improvement and optimization opportunities, including review of SOPs and MBRs. Perform job functions and responsibilities independently and with limited direction. Leads the development, design of new product/ process technology advancements; is the key technical contributor. Solves complex, high impact design/ development problems. Qualifications Bachelor's or Master's Degree in Mechanical, Electrical, or Chemical Engineering or equivalent education/experience. 4+ years of combined experience in pharma/biopharma and fine chemicals industry to include 3+ years of experience with process and instrumentation diagrams, facility layouts, equipment sizing calculations, user requirement specifications (URSs), standard operating procedures (SOPs) and process troubleshooting. Preferred Skills: 2+ years of experience supporting small to large-sized projects through all phases, including architectural and engineering design, design review, process safety management, process hazard analysis, equipment procurement, installation, commissioning, and qualification, is desirable. Self-motivated, hands-on problem solver with the ability to work within multi-disciplinary teams, including process development, manufacturing, validation, quality, safety, and project management personnel. Familiarity with current ASME BPE sanitary piping and equipment design standards, electrical standards such as National Fire Protection Association / National Electrical Code (NFPA 70 / NEC) and International Fire and Building Codes. Project Management experience in biopharma. Experience with design and programming of industrial control systems, including SCADA, PLCs, and BAS and validation documentation, including installation, operational and performance qualification (IQ/OQ/PQ) protocols. Engineering, communication, and organizational skills to support the safe, efficient, and compliant production of API within a fast-paced, dynamic, contract manufacturing facility. #LI-DT1 Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least November 10, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $103,200.00 - $161,250.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit *************************************** Required: 10% of the TimeShift: DayDuration: No End DateJob Function: Manufacturing

Duties and Responsibilities: Work effectively with the Quality, Operations, and R&D departments to perform all work accurately, with a sense of urgency and a positive attitude. Activities include the following: In-Process and Final Device Inspection and Test : Support Manufacturing as the QC inspector for clean-room & packaging inspection activities. Perform and document in-process and final inspection/test of devices and sub-assemblies. Provide inspection/test assistance to R&D, Operations and Quality Engineering in support of design and process verification/validation activities. Receiving Inspection and Test : Perform and document receiving inspection/test of device components & raw materials in accordance with drawings/specifications. Maintain accurate & timely records of inspection activities and recording such activities in the QC Receiving Log. Non-Conforming Materials : Identify, segregate and quarantine non-conforming materials resulting from inspection activities. Initiate NCRs and notify the workstream owner in a timely manner. Execute and record disposition activities in accordance with approved NCRs. Microbiological Monitoring : Participates in periodic microbiological and particulate testing of the cleanroom and products as required. Returned Goods Authorization : Perform timely inspections and maintain accurate records of all returned TriSalus products through the RGA process. Correctly dispositions returned product as defined in approved procedures. Quality Record maintenance : Receive, verify, scan and physically file Quality Records in an organized manner as needed. Shipping QC : Verify TriSalus products and associated paperwork are accurate and complete prior to shipment. Audit Assistance : Help retrieve, review, organize and re-file documentation during all TriSalus site audit activities (internal, FDA, ISO registrar). GP Dynamics : Transfer released materials in the ERP software for material management as needed. Training Record support : Enter complete training/certification records into the eQMS as needed. General : Perform other quality inspection, test or administration activities as assigned. Qualifications Education & Certifications: High School diploma. Advanced education or certifications a plus. Work Experience: 2+ years of Quality Control / Inspection experience in a medical device or similar technical product manufacturing company. Experience working with sterile disposable products in a cleanroom environment a plus. Knowledge, Skills & Abilities: Able to read and interpret engineering drawings, specifications and detailed technical documents. Able to read and follow quality procedures and detailed work instructions (QLPs/OPs). Able to perform component and product inspection/testing using tools such as microscopes, calipers, micrometers, pin gauges, depth gauges, pull force test systems and vision measuring systems. (Sufficient knowledge to select and use the correct measurement tool for the required inspection accuracy. Able to accurately document results of inspections using good documentation practices. Able to understand and apply inspection sampling plans, such as C=0 or ANSI Z1.4. Able to utilize basic math skills. Able to use MS Word and MS Excel. Must possess strong attention to detail. Possess good communication skills and able to interact with peers in a professional manner. Possess knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485). Demonstrates excellent critical thinking skills. Ability to adapt to and rapidly learn new processes. Strong verbal and written communication skills and confidence in making inspection related decisions. Participates as a member of cross functional technical teams to support process improvements, special projects and investigations as needed. Approaches work tasks with a positive attitude and seeks feedback on performance to continually improve. Physical Requirements: Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. Must be able to lift and carry up to 30 lbs. Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.

Duties and Responsibilities: Work effectively with the Quality, Operations, and R&D departments to perform all work accurately, with a sense of urgency and a positive attitude. Activities include the following: * In-Process and Final Device Inspection and Test: Support Manufacturing as the QC inspector for clean-room & packaging inspection activities. Perform and document in-process and final inspection/test of devices and sub-assemblies. Provide inspection/test assistance to R&D, Operations and Quality Engineering in support of design and process verification/validation activities. * Receiving Inspection and Test: Perform and document receiving inspection/test of device components & raw materials in accordance with drawings/specifications. Maintain accurate & timely records of inspection activities and recording such activities in the QC Receiving Log. * Non-Conforming Materials: Identify, segregate and quarantine non-conforming materials resulting from inspection activities. Initiate NCRs and notify the workstream owner in a timely manner. Execute and record disposition activities in accordance with approved NCRs. * Microbiological Monitoring: Participates in periodic microbiological and particulate testing of the cleanroom and products as required. * Returned Goods Authorization: Perform timely inspections and maintain accurate records of all returned TriSalus products through the RGA process. Correctly dispositions returned product as defined in approved procedures. * Quality Record maintenance: Receive, verify, scan and physically file Quality Records in an organized manner as needed. * Shipping QC: Verify TriSalus products and associated paperwork are accurate and complete prior to shipment. * Audit Assistance: Help retrieve, review, organize and re-file documentation during all TriSalus site audit activities (internal, FDA, ISO registrar). * GP Dynamics: Transfer released materials in the ERP software for material management as needed. * Training Record support: Enter complete training/certification records into the eQMS as needed. * General: Perform other quality inspection, test or administration activities as assigned. Qualifications Education & Certifications: * High School diploma. Advanced education or certifications a plus. Work Experience: * 2+ years of Quality Control / Inspection experience in a medical device or similar technical product manufacturing company. * Experience working with sterile disposable products in a cleanroom environment a plus. Knowledge, Skills & Abilities: * Able to read and interpret engineering drawings, specifications and detailed technical documents. * Able to read and follow quality procedures and detailed work instructions (QLPs/OPs). * Able to perform component and product inspection/testing using tools such as microscopes, calipers, micrometers, pin gauges, depth gauges, pull force test systems and vision measuring systems. (Sufficient knowledge to select and use the correct measurement tool for the required inspection accuracy. * Able to accurately document results of inspections using good documentation practices. * Able to understand and apply inspection sampling plans, such as C=0 or ANSI Z1.4. * Able to utilize basic math skills. * Able to use MS Word and MS Excel. * Must possess strong attention to detail. * Possess good communication skills and able to interact with peers in a professional manner. * Possess knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485). * Demonstrates excellent critical thinking skills. * Ability to adapt to and rapidly learn new processes. * Strong verbal and written communication skills and confidence in making inspection related decisions. * Participates as a member of cross functional technical teams to support process improvements, special projects and investigations as needed. * Approaches work tasks with a positive attitude and seeks feedback on performance to continually improve. Physical Requirements: * Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. * Must be able to lift and carry up to 30 lbs. * Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.

Duties and Responsibilities: Work effectively with the Quality, Operations, and R&D departments to perform all work accurately, with a sense of urgency and a positive attitude. Activities include the following: In-Process and Final Device Inspection and Test: Support Manufacturing as the QC inspector for clean-room & packaging inspection activities. Perform and document in-process and final inspection/test of devices and sub-assemblies. Provide inspection/test assistance to R&D, Operations and Quality Engineering in support of design and process verification/validation activities. Receiving Inspection and Test: Perform and document receiving inspection/test of device components & raw materials in accordance with drawings/specifications. Maintain accurate & timely records of inspection activities and recording such activities in the QC Receiving Log. Non-Conforming Materials: Identify, segregate and quarantine non-conforming materials resulting from inspection activities. Initiate NCRs and notify the workstream owner in a timely manner. Execute and record disposition activities in accordance with approved NCRs. Microbiological Monitoring: Participates in periodic microbiological and particulate testing of the cleanroom and products as required. Returned Goods Authorization: Perform timely inspections and maintain accurate records of all returned TriSalus products through the RGA process. Correctly dispositions returned product as defined in approved procedures. Quality Record maintenance: Receive, verify, scan and physically file Quality Records in an organized manner as needed. Shipping QC: Verify TriSalus products and associated paperwork are accurate and complete prior to shipment. Audit Assistance: Help retrieve, review, organize and re-file documentation during all TriSalus site audit activities (internal, FDA, ISO registrar). GP Dynamics: Transfer released materials in the ERP software for material management as needed. Training Record support: Enter complete training/certification records into the eQMS as needed. General: Perform other quality inspection, test or administration activities as assigned. Qualifications Education & Certifications: High School diploma. Advanced education or certifications a plus. Work Experience: 2+ years of Quality Control / Inspection experience in a medical device or similar technical product manufacturing company. Experience working with sterile disposable products in a cleanroom environment a plus. Knowledge, Skills & Abilities: Able to read and interpret engineering drawings, specifications and detailed technical documents. Able to read and follow quality procedures and detailed work instructions (QLPs/OPs). Able to perform component and product inspection/testing using tools such as microscopes, calipers, micrometers, pin gauges, depth gauges, pull force test systems and vision measuring systems. (Sufficient knowledge to select and use the correct measurement tool for the required inspection accuracy. Able to accurately document results of inspections using good documentation practices. Able to understand and apply inspection sampling plans, such as C=0 or ANSI Z1.4. Able to utilize basic math skills. Able to use MS Word and MS Excel. Must possess strong attention to detail. Possess good communication skills and able to interact with peers in a professional manner. Possess knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485). Demonstrates excellent critical thinking skills. Ability to adapt to and rapidly learn new processes. Strong verbal and written communication skills and confidence in making inspection related decisions. Participates as a member of cross functional technical teams to support process improvements, special projects and investigations as needed. Approaches work tasks with a positive attitude and seeks feedback on performance to continually improve. Physical Requirements: Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. Must be able to lift and carry up to 30 lbs. Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.

Validation Engineer The Validation Engineer reports directly to the Validation Manager. The role is responsible for acting as a SME for the Commissioning, Qualification, and Validation (CQV) processes for the site. This includes commissioning and qualification of the equipment, process validation, facilities qualification, utilities qualification, shipping validation, and program maintenance. The Validation Engineer will work closely with Quality, Engineering, and Operations teams to ensure processes, equipment, and systems are compliant, reliable, and inspection-ready. This role ensures all systems operate under regulations to ensure the production of quality products for the Company's 503B cGMP manufacturing facility. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: Works on projects/matters in a supporting capacity. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group. Utilizes Project Management skills to plan and coordinate efforts with a cross-functional team. Completes tasks in a timely fashion and communicates task status to management and/or project team. Adheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, and CAPAs. Coordination of Validation activities with stakeholders. Supports in writing and executing protocols for Validation work. Identifies and resolves non-conformances/discrepancies encountered during IQ/OQ/PQ execution and work with cross function team to implement mitigation solutions. Generates reports and summarizes results, including confirming the document is suitable to be shared with regulatory agencies. Supports creation or revision of Validation templates for protocols and reports. Supports creation and review of Engineering Documentation (URS, FS, SAT, FAT). Supports project work as a specialist on complex technical matters. Supervisory Responsibilities: N/A Experience and Necessary Competencies: Bachelors degree in STEM field required; i.e. engineering, chemistry, or relevant industry experience. 4+ Years of validation experience preferably in a highly regulated environment. Experience in project management preferred Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.) Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through. Willingness to support tasks outside normal job description, as needed. Can-do attitude! Ability to create technical and professional documents. Strong attention to detail and accuracy. Ability to multi-task, with strong organization and time-management. Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis. Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus! Proficient written, verbal and oral English communication skills are required. Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel. Physical Requirements: Ability to stand or sit for extended periods of time. Ability to lift, push and pull up to 50 pounds periodically. Ability to maintain a gowning qualification and adhere to aseptic practices. Benefits: 100% employer paid medical plan. Dental & Vision insurance options including FSA & HSA Employer Paid Life Insurance & Employee Assistance Program Short Term & Long-Term Disability Insurance Up to 4% 401K Matching (100% vested on day one!) Generous Paid Time Off Options - vacation, sick, paid leave and holidays! $5,250 Annual Tuition Reimbursement after 6 months $1,000 Referral Bonus Program with no limit Eligible for annual bonus program Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

WHO WE ARE Biofire Technologies is on a mission to give gun owners better tools for reducing preventable gun injuries and deaths, especially among children. We believe our technology, combined with a best-in-class customer experience, will define the future of firearms safety for the next generation. Our mission-driven approach has earned support from the firearm community, the tech world, and the media. Biofire employees encompass a diverse range of talents, including world-class engineers who have designed and tested firearms, medical devices, robots, cars, satellites, rockets, and supersonic jets; expert technicians from aerospace, defense tech, special forces, and gunsmithing; and elite operators from high-tech, advanced manufacturing, and regulated industries. Whether building the product or powering the company behind it, every Biofire team member is united by an obsession with safety, reliability, and operational excellence. OUR CULTURE Reducing accidental firearm injuries and deaths requires original thinking and authentic collaboration, so we're deeply invested in building a team and culture that can achieve our mission together. Team members enjoy autonomy and flexibility from day one, so expect to be immediately tasked with solving challenging problems and building new systems that work. We'll hold you accountable for executing audacious goals, giving and receiving honest feedback, and helping your teammates succeed. You'll receive respect, kindness, and support from every direction while you figure out how to get it all done. ABOUT THE ROLE As a Supplier Industrialization Engineer / Supplier Quality Engineer (SIE / SQE) at Biofire, you will fill a high-profile, cross functional position and play an integral role enabling development and production flow of Biofire's critical supply base. You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals. To succeed, you will need to effectively team with Suppliers, Product Engineers, Supply Chain and Production Teams across a product's life cycle to ensure an uninterrupted, on time supply of PCB / PCBAs to Biofire's production line. You'll also need to be comfortable task-switching between an SIE role for products in a New Product Introduction (NPI) phase and an SQE role for products in a production state. If you're excited about building a PCB / PCBA supply chain, we'd love to hear from you. KEY RESPONSIBILITIES Day-to-day responsibilities of the role will include: [SIE] Own and manage the PCB/PCBA category to enable Supplier qualification from Prototype to Volume Production phases; [SIE] Partner with Product Engineering to support the design development process, provide design for manufacturability (DFM) feedback, and help generate product data (drawings details, BOM information, layouts, test requirements, and part requirements) that leads to supplier quality success; [SIE] Vet Supplier's production and quality control capabilities and capacity, factory layouts, subordination supply chains to allow for new part and Supplier combinations to be included on the Approved Vendor List; [SIE] Own bring up of new Supplier production tooling and lines to ensure materials, processes and tools are capable of meeting product performance, quality and capacity requirements; [SIE] Own capacity expansion readiness and production ramp at PCB/ PCBA Suppliers. [SIE] Implement robust end of line (EoL) testing protocols at Suppliers; [SQE] Deliver predictable PCB / PCBA supply to the development programs, production programs, and manage exceptions/containments/deviations for supplier technical performance, particularly in the development phases; [SQE] Own the elimination of supplier risk to improve quality and reliability across the product lifecycle; [SQE] With Supply Chain, drive Supplier quality development processes throughout product development stages through design reviews, supplier process development, testing, and qualification; [SQE] With Supply Chain, drive overall supplier performance for cost, quality, and on-time delivery; [SQE] Review supplier processes and capabilities to ensure PCB / PCBA functionality can be tested at Supplier facilities to ensure shipment of conforming product; [SQE] Prepare, support, and lead Supplier onsite audits and reviews for contract deliverables for quality management and compliance; [Both] Implement and lead a Biofire root cause task force and own Root Cause / Corrective Action (RCCA) at Suppliers. QUALIFICATIONS We understand that not all applicants will possess skills that perfectly align with our job qualifications. At Biofire, we appreciate diverse experiences from various industries, and we encourage all individuals who meet the necessary qualifications to submit their applications. While having the "desired" qualifications may strengthen a candidate's profile, we also welcome applicants with alternative experiences to apply. Bachelor's degree in supply chain, engineering, or related technical field. 5+ years of experience in supplier quality and industrialization within a manufacturing environment, with specific category technical expertise in PCB / PCBA manufacturing, SMT processing, CAD, and Geometric Dimensioning and Tolerancing (GD & T). Working knowledge of product development methodologies such as Failure Modes and Effects Analysis (FMEA), Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP) elements such as Measurement Systems Analysis (MSA), and quality improvement techniques. Ability to travel to Supplier sites for evaluation / qualification / audit. COMPENSATION AND BENEFITS In addition to competitive pay, as a full-time employee at Biofire you are eligible for: Stock Options in Biofire, 401(k), HSA - and other financial benefits Medical Insurance - including plan options with $0 payroll deduction Dental, Vision and Life Insurance Plans - with $0 payroll deduction 3 Weeks Vacation and Sick time (Flex Time for salary positions), and 13 Paid Holidays Parental Leave - and other family-building, adoption and surrogacy benefits The compensation range for this role is $150,000 - $180,000/annual salary + stock options + benefits. Pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. LOCATION This is a full-time, salaried role. Our dog-friendly, state-of-the-art headquarters is located in beautiful Broomfield, Colorado, between Boulder and Denver. The team regularly engages in collaborative in-person sessions at our vibrant office space, but you will be offered the flexibility to work from home as needed. We expect you to bring your very best, and in return, we will provide the support necessary for you to excel. You'll collaborate with colleagues you appreciate, respect, and find inspiration from, and have access to all the technical resources needed. DIVERSITY & INCLUSION We're bringing innovation to a technological problem that has persisted for decades, so we depend on diverse, inclusive, and collaborative teams to break new ground and do great work. We welcome people from all qualified backgrounds, and we don't discriminate based on race, religion, color, political affiliation, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. ELIGIBILITY This role handles information subject to US Export Control Regulations. Applicants must be (a) a citizen of the United States; (b) a lawful permanent resident of the United States (“Green Card” holder); or (c) a person admitted into the United States as an asylee or refugee to be considered for the position.

Duties and Responsibilities: Participate in the development and improvement of manufacturing processes for SmartValve Manufacturing and catheter-based systems in accordance with FDA and international regulations. Evaluate, develop, and sustain processes to meet product performance and manufacturing yield requirements. Constantly identify opportunities to reduce cycle time and waste. Develop and implement plans to capitalize on these opportunities. Evaluate and modify process flow as necessary to improve efficiency. Develop tools, fixtures, and processes to meet product and process capability requirements. Create and maintain process validation master plan. Develop, qualify, and validate new manufacturing processes as needed. Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services. Build and validate test equipment, conduct testing of product, and analyze data as needed. Follow approved procedures for activities conducted and update or generate new procedures as needed. May supervise operators, technicians, or other engineers. Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485. Assure individual and group safety when conducting all activities. Maintain effective communications with supervisor and peers in project activities. As necessary, suggest strategic direction for specific projects. Support day-to-day manufacturing activities. Qualifications Education & Certifications: Minimum of four-year engineering degree or equivalent experience. Work Experience: 0-2 years experience in a medical device manufacturing environment is required. Knowledge, Skills & Abilities: Cardiovascular catheter experience preferred; will consider candidates with self-expanding stent experience. Knowledge with chemistry and good laboratory practices. Familiarity with Six Sigma principles preferred. Physical Requirements: Able to work in an industrial environment.

Duties and Responsibilities: Participate in the development and improvement of manufacturing processes for SmartValve Manufacturing and catheter-based systems in accordance with FDA and international regulations. Evaluate, develop, and sustain processes to meet product performance and manufacturing yield requirements. Constantly identify opportunities to reduce cycle time and waste. Develop and implement plans to capitalize on these opportunities. Evaluate and modify process flow as necessary to improve efficiency. Develop tools, fixtures, and processes to meet product and process capability requirements. Create and maintain process validation master plan. Develop, qualify, and validate new manufacturing processes as needed. Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services. Build and validate test equipment, conduct testing of product, and analyze data as needed. Follow approved procedures for activities conducted and update or generate new procedures as needed. May supervise operators, technicians, or other engineers. Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485. Assure individual and group safety when conducting all activities. Maintain effective communications with supervisor and peers in project activities. As necessary, suggest strategic direction for specific projects. Support day-to-day manufacturing activities. Qualifications Education & Certifications: Minimum of four-year engineering degree or equivalent experience. Work Experience: 0-2 years experience in a medical device manufacturing environment is required. Knowledge, Skills & Abilities: Cardiovascular catheter experience preferred; will consider candidates with self-expanding stent experience. Knowledge with chemistry and good laboratory practices. Familiarity with Six Sigma principles preferred. Physical Requirements: Able to work in an industrial environment.