Sr. Injection Molding Engineer - Columbus, OH
Product engineer job at Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Abbott Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac, PediaSure, Pedialyte, Ensure and Glucerna. - to help get the nutrients they need to live their healthiest life.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
* Fast paced work environment where your safety is our priority
* Production areas that are clean, well-lit and temperature-controlled
* Training and career development, with onboarding programs for new employees and tuition assistance
* Financial security through competitive compensation, incentives and retirement plan.
* Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
* Vacation - 3 weeks accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
* The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: **********************
Sr. Injection Molding Engineer
This position is responsible for packaging development, testing and qualification of new packaging materials & products of global brands for Abbott Nutrition. Programs will encompass development & commercialization of Packaging for nutritional products. Effective ability to collaborate across divisional and regional boundaries is critical to be successful.
WHAT YOU'LL DO
Technical Leadership & Design Development
* Serve as a developing injection molding subject matter expert providing guidance and leading concept design and development from initial concept through launch, including DFM reviews, process feasibility studies, 3D/2D design evaluations, and competitive benchmarking
* Develop and prototype new packaging concepts for application in Nutrition products, leveraging prototyping tools to accelerate decision-making and design refinements
Project Management & Scale up
* Manage injection molding projects through all phases (concept to launch) with timely execution and specification compliance
* Lead pilot runs and scale up including design & development of production tools, automation and manufacturing cells including engineering studies, mold qualification studies, and testing leading to commercialization.
Supplier Management & Collaboration
* Manage injection molding suppliers, mold makers, and contract manufacturers with technical rigor to optimize time-to-market and cost.
* Recommend mold tooling improvements, capital equipment, and guide suppliers to meet project scope, deliverables, and KPIs
* Collaborate cross-functionally with R&D, Packaging equipment teams, Marketing and external engineering resources
EDUCATION AND EXPERIENCE YOU'LL BRING
Required:
* Bachelor's degree in engineering required with preference for Plastics Engineering.
* Minimum 6+ years' experience in Injection molding industry.
* Experience in plastics materials, concept development, prototyping, development, and scale-up through launch with focus on injection molding and high-volume manufacturing.
The base pay for this position is $75,300.00 - $150,700.00. In specific locations, the pay range may vary from the range posted.
Auto-ApplyAssociate OT Engineer - Tipp City, OH
Product engineer job at Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Nourish the world and your career as part of the Nutrition team at Abbott.
Our business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac , PediaSure , Pedialyte , Ensure , Glucerna - to help get the nutrients they need to live their healthiest life.
This position works out of our Tipp City, OH location one of Abbott's newest nutrition manufacturing facilities with technology that enhances production efficiency and product quality. Join us and you'll be part of a family that's dedicated to innovation and excellence and dedicated to nourishing millions of families around the world.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your safety is our priority
Production areas that are clean, well-lit and temperature-controlled
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation and incentives
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: **********************
WHAT YOU'LL DO
Provide support to manufacturing operations and project engineers to improve or maintain current plant manufacturing technology networks and hardware, as required.
Basic understanding manufacturing operation data systems including hardware and software. For example: OSI PI, Ignition, ZPI data servers, Kepware, PTC, industrial IIoT, SPC
Software change management and asset monitoring servers
Manufacturing Human Machine Interfaces (HMI)
Work with OT team and IT support team to maintain secured digital infrastructure for manufacturing operation.
Self-starter that will initiate plans to acquire new skills required by changes in technology.
Interface frequently with inter-organizational and outside customer contacts.
Represent the organization in providing solutions to difficult technical issues associated with specific projects.
Prepare written communication. Convey information effectively through formal and informal documents with team members, designers, technicians, and other technical personnel, both internal and external to Abbott, using appropriate communication protocols.
Establish networks. Follow through on project goals; contribute willingly and incorporate the ideas of others; share resources, knowledge, and accountability to benefit the objectives of the business, e.g. participate in team meetings; serve as a functional member in cross-project design review.
Build relationships. Initiate and cultivate open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others' needs, promoting common goals, and following through on commitments, e.g. offers assistance; interact effectively with stakeholders at appropriate levels of the organization.
Resolve underlying problems. Identify full range of customer/ client needs and propose solutions to address them; make alterations in products or services to better meet (recognized or unrecognized) customer need, e.g. partners with an outside vendor to provide a better deliverable.
Report through centralized engineering organization. Work under general direction. Independently determine and develop approach to solutions.
Responsible for following standardized procedures and best practices, replicated globally. Require frequent interactions with peers across sites.
Identify and quantify technical risks and their consequences relative to the success of part of a project; recommends appropriate action, e.g. reports calculations and recommendations in terms concrete enough for management to make an informed decision.
Decisions or recommendations would typically achieve department/project objectives.
Drives functional performance that ensures the highest standards in quality, customer service, and regulatory compliance are met.
Has demonstrated competency within the area of manufacturing controls or IT systems.
Interacts well with diverse groups within engineering and has a technical background in health care, nutritional products, consumer goods, pharmaceutical, or similar industries (preferred).
Has basic understanding of data validation requirements and good documentation practices.
EDUCATION AND EXPERIENCE YOU'LL BRING
Required:
Associate's degree in computer science or computer engineering or closely related discipline, or equivalent technical experience. Technical experience may contribute towards the desired education.
Desired 2+ years of significant IT, engineering, and/or operational experience.
The base pay for this position is
$50,000.00 - $100,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:EngineeringDIVISION:ANSC Nutrition Supply ChainLOCATION:United States > Tipp City : Main/Liquid PlantADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:NoMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyStructural Project Engineer
Orlando, FL jobs
Structural Project Engineer - Lead. Collaborate. Build What Lasts.
If you're a Structural Engineer who thrives on leadership, client collaboration, and seeing your designs come to life, this role offers everything you've been looking for.
As a Structural Project Engineer, you'll take ownership from concept through construction, working alongside in-house MEP, civil, and architectural teams-all under one roof. That means smoother coordination, smarter delivery, and a real opportunity to shape project outcomes.
About the Firm
A people-first, nationally recognized firm with a strong Florida presence. You'll lead impactful projects, gain direct client exposure, and design high-quality steel, concrete, and masonry structures across a wide mix of commercial and community developments.
What You'll Do
Lead structural design from concept to completion
Serve as the primary structural contact for clients, ensuring clear and confident communication
Oversee timelines, delegate effectively, and manage quality across deliverables
Collaborate closely with multidisciplinary teams and lead project meetings
Mentor junior engineers and contribute to a culture of learning and technical excellence
What You'll Bring
Professional Engineer (P.E.) license
7+ years of experience in building structure design and project delivery
Proven success managing mid-to-large-scale structural projects
Strong understanding of construction methods, value engineering, and project costs
Excellent communication and coordination skills
Why You'll Love It
Collaborative, integrated design environment
Clear career development and visible leadership pathways
Competitive compensation and work-life balance in Orlando or Melbourne, FL
If you're ready to lead complex projects and join a forward-thinking, multidisciplinary team, we'd love to connect.
Apply today or reach out to start the conversation.
About the Search:
This role is being managed by Conrad Consulting, a recruitment agency specializing in the architecture, engineering, and construction (AEC) industry. With over 30 years of experience, we partner with respected firms to connect top civil and structural engineers with career-defining opportunities. Learn more about us and browse additional roles at ********************************
Senior Databricks Engineer
Houston, TX jobs
Job Title: Senior Azure Databricks Engineer
Company: Aarista/ Altea Healthcare IT
Job Type: Full-Time
About Us:
Our mission is to improve outcomes for Chronic Care patients who are dependent on multiple daily medications. Our proprietary and vertically integrated EMR technology solutions enable providers to enhance medication adherence through improved access, owned physician network, information
Position Overview:
We are looking for a Senior Databrick engineer and lead. This person will play a key role on the core development team that is working on supporting and building our next generation suite of products, Revenue Cycle Management system. As a member of our core development team, this person will contribute significantly to designing and implementing various product features. In addition to bringing their experience building using the Microsoft stack, this role will also require learning and implementing solutions using other technologies on an as needed basis. We are an exciting healthcare startup company, so we need someone that is agile since changes are expected.
Visa and Sponsorship Information:
Please note that Altea Healthcare is unable to provide sponsorship for visas or work permits.
Your Role:
Support, design and develop RCM software covering Databrick/DataFactory with main technology stack GoLang and MongoDB
Brainstorm with your team to conceptualize and build new features.
Experience with the Azure-based infrastructure and help us to leverage cloud technologies to ensure we can scale in line with customer adoption.
Partner with business analysts and other developers in order to fully understand product requirements and implement solutions which meet these requirements.
Provide technical leadership including architecture design, coding, code review, practices and skills development.
Provide development and operational support of Aarista RCM platform.
You:
You thrive in a team environment but can also work independently.
You are passionate about using your technical knowledge and skills to solve real business problems and are motivated by understanding the value that your work adds.
A self-starter that can manage their own workload and an ever-growing task list.
A team player and leader.
Problem solving of potential roadblocks which could potentially impact patient care, strategic, and technical goals of the business.
Expert in Azure Databricks/DataFactory
Working knowledge with MongoDB
Working knowledge of relational databases such as SQL Server, Azure SQL
Has healthcare EDI 835/837 and clearing house experience
You are passionate about creating innovating and exciting new technology and want to provide end users with the best possible experience.
Have experience with Software development Lifecycle (SDLC) including system requirements collection, architecture, design, development, testing, maintenance and enhancement across a variety of technologies.
Required Experience:
Azure Databrick, Notebook
Azure Data Factory
PySpark
Scala
Nice to have:
MongoDB
MS SQL, Azure SQL (SQL Server)
Azure Data lake store
Data modeling, UML and Design Patterns
Azure experience
Welding Engineer - 2nd Shift
Windsor, CT jobs
What You will Do:
Implementing the restart of legacy heat exchanger products
Work alongside the manufacturing engineering team and shop floor by creating work instructions for operations
Can develop, produce, and modify process operation and assembly sheets. (Solumina preferred)
Knowledge of GD&T and can integrate within a production process. Keen understanding of B/P interpretation as it relates to specification requirements.
May have a working knowledge of 3D modeling. (NX preferred)
Experienced with basic manufacturing processes, methods, and techniques. Particularly in aluminum and steel brazing, welding, and machining. Understanding of Heat Exchanger manufacturing preferred.
Ability to mark-up, edit, and update specifications for weld processes.
Investigate welding related issues to improve product performance and increase productivity.
Develop repair procedures and assess flaws to determine the fitness-for-service of structures
Develop standards, materials, weld joint design, and welding processes
Develop welding process procedure qualification, suppler qualification, and product testing
Troubleshoot welding problems and provide corrective solutions
Ability to manage various projects and process tasks while following approval process for authoring operation sheets
Communicates technical subject matter proficiently, both written and verbally.
Responds effectively in high-paced environment.
Production troubleshooting (cause & effect) must be a strength.
Can rationalize and implement inspection methods and techniques.
Skilled in project management and follows up on tasks daily.
Create presentations based on process data and results to show opportunities for productivity improvements and cost savings.
Ability to manage various project and process tasks related to product quality.
How You Will Get Here:
Minimum of 3 - 6 years' experience
Familiarity with Teamcenter and NX preferred
Proficient in Microsoft Office, Word, Excel, Outlook, PowerPoint
Self-motivated to ensure accountability, disciplined to improve processes, passionate about engineering, and organized to track numerous work streams
Understanding of manufacturing processes, Sheet Metal and Heat Exchanger manufacturing preferred
Experienced in AS9100 and basic manufacturing processes, methods, and techniques.
Knowledge of machines and tools required to fabricate and manufacture Sheet Metal, particularly in aluminum and steel brazing, welding, and machining.
Excellent verbal and written communication
Organized with the ability to multi-task while driving actions to completion
Excellent communication and teamwork skills
Solid computer skills, including Microsoft Office with emphasis on Excel
Familiarity with SAP preferred
Pay Range: $80,000 - $100,000
Compensation decisions are made based on factors including experience, skills, education, and other job-related factors, in accordance with our internal pay structure. We also offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan.
Work Requirements:
This role is considered an on-site, second shift position located in Windsor Locks, CT.
You must be able to commute to and from the location with your own transportation arrangements to meet the required working hours.
Typical 8-hour days plus lunch / 40-hour weeks / hours are 3:00PM to 11:30PM, 2nd Shift
Shop floor environment, which may include but not limited to extensive walking, and ability to lift up to 40 lbs.
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Referral program
Vision insurance
Short/Long Term Disability
Tech Services - Senior Associate Engineer
Rocky Mount, NC jobs
Use Your Power for Purpose
As a Senior Tech Ops Engineer, you will play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives.
The Sr Tech Ops Engineer provides strategic direction and technical expertise for site Commissioning and Qualification (C&Q) activities for equipment, utilities and facilities. To include execution of C&Q work for utilities, facilities and global applications as well as maintenance and execution of periodic performance qualification schedule and reviews. This role serves as a Center of Excellence, driving alignment with global and industry engineering standards. The engineer supports site critical programs related to C&Q while also supporting capital project execution and site-wide technical initiatives. The position plays a key role in shaping the site's technology roadmap, ensuring operational excellence, and fostering a self-sustaining technical work structure for the Focus Factory Manufacturing Technology teams.
What You Will Achieve
In this role, you will:
S/he acts as the SME for C&Q work for Utilities, Facilities and Equipment across the site. Individual must have knowledge and application experience of technical design reviews, commissioning and qualification for pharmaceutical systems.
S/he will be expected to work routinely with cross functional groups throughout the site for process improvements and implementation. S/he must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Person will be responsible for interfacing with auditors and presenting on site processes.
S/he organizes, coordinates and supports testing associated with the development of new process technologies and the support of new systems introductions. S/he works closely with site Quality and Engineering resources to ensure appropriate C&Q of site systems is achieved and maintained against procedures and industry guidance. S/he plans, generates, reviews and approves site technical reports, to include validation plans/protocols, design specs, Risk Assessments.
S/he will be expected to ensure site alignment to global procedures and work instructions related to C&Q work. Provide ongoing training, guidance and templates to support the technical teams within the Focus Factories.
S/he will be expected to confirm C&Q pre-requisites are met and supported by approved documentation in accordance with procedures and industry standards. Oversee and assist team members and contractor resources with their assigned projects. Support development and design of C&Q strategies, studies, draft and/or review project validation plans and documentation.
S/he to provide input in technology transfer, risk assessments, validation deviations and/or quality deviation investigations to identify root causes and define correction and/or preventive actions (CAPA). Author and/or review risk assessment documents. Review investigations, commitments, procedures, and batch records. Provide technical input and complete SME impact assessment to proposed change controls vetted for implementation. Participate in teams assembled to complete change control implementation for new and existing systems.
Here Is What You Need
(Minimum Requirements)
Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
Solid knowledge/understanding of C&Q strategies
Understanding of various pharmaceutical equipment, utility and facility systems, preferably related to sterile injectable operations.
Solid leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
Must be self-motivated and work with little direction
Good interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
An aptitude for understanding process technology and controls applications, decision making ability, and excellent oral and written communication skills are essential. Demonstrated ability to interact effectively with multiple levels of the organization. Candidate must possess flexibility to respond to changing conditions and priorities.
Understanding of global regulations on GMP processes.
Bonus Points If You Have
(Preferred Requirements)
Technical writing experience.
Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices.
Working knowledge of Food and Drug Administration (FDA) Regulations/Guidance, and Good Manufacturing Practices (GMP).
Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
PHYSICAL/MENTAL REQUIREMENTS
Remains organized & positive in ambiguous and fast-paced, rapidly changing environment
Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
Ability to process complex information and make recommendations with incomplete data set
Ability to adjust work schedule to meet business needs - overtime, off shift, weekends.
Ability to travel
Able to stand for extended hours for test runs and performance monitoring of processes - will include working within special gowning for cleanroom access
Able to climb ladders/steps
Able to lift items of 25lbs
Strategic thinker for issue resolution
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Pfizer operates 24/7 across most of the business units. Employee must have the ability to work extended hours, holidays and/or weekends as needed. Limited travel may be required to support OEM equipment design reviews and/or Factory Acceptance Testing of new equipment. Employee will be expected to periodically work within clean room areas requiring special gowning.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Engineering
Principal Manufacturing Process Engineer
Washington, DC jobs
Use Your Power for Purpose
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will contribute to delivering medicines to the world at an accelerated pace by envisioning new possibilities and taking decisive action. Your role in the design and development of manufacturing processes, as well as in maintenance and reliability support, is essential for providing timely access to necessary medications. Working alongside our innovative team, you will help expedite the delivery of medicines globally by imagining what can be achieved and making it happen.
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
The Principal Process Engineer supports the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule for mAb products . The Principal Process Engineer will lead interdisciplinary and cross functional teams, to own and implement process improvements, and lead/participate in process troubleshooting.
How You Will Achieve It
Supports manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
Point of Contact for the execution and issue resolution associated with process equipment commissioning, qualification and validation.
Owns troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
Delivers Right first time execution and continuous improvement; Monitor, Identify and/or Communicate process and compliance trends in real time.
Participate in the authoring role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
Responsible for remaining current on assigned training.
Leads Lean Manufacturing, Sustainability and Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
Leads in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
Generates work requests when issues arise with facility / manufacturing equipment. Provides support to maintenance to facilitate resolution, when needed. Point of contact for emergency work orders.
Skilled in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
Identifies the need for escalation through various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
Lead cross-functional project teams through high-risk technical assessments and develop complex engineering solutions.
Leads and coaches beginner and intermediate Process Engineers through complex troubleshooting, investigations, and projects
Oversee and conduct supplier technical audits and corporate audits.
Actively share knowledge within the team through established systems.
Here Is What You Need (Minimum Requirements)
BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
Demonstrated experience in product development, manufacturing science and technology, sterilization or process validation, or Process Engineering within the pharmaceutical industry
Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, and design control
Strong history of problem-solving skills, project and task management skills
Ability to manage priorities and lead others under pressure
Strong verbal and written presentation communication skills
Bonus Points If You Have (Preferred Requirements)
Proven ability to work collaboratively in a cross-functional team environment
Strategic planning and forecasting skills
Ability to facilitate agreements between various teams
Physical / Mental requirements
Position requirements are typical for an office-based work environment with some lab floor exposure and clean room gowning will be required.
Ability to work on own initiative.
Strong technical management and organizational skills
Good leadership and communication abilities
Strong problem-solving skills
Non-Standard work schedule, travel or environment requirements
This role is standard day Monday through Friday (8 hrs), but at times it will be necessary to work according to the manufacturing shift schedules (1st, 2nd or 3rd shift, weekends) to support execution of batch records when manufacturing batches that are manufactured outside.
Limited Travel 10%.
Other job details
Last Day to apply: December 9th, 2025
Work Location Assignment: On Premise
The annual base salary for this position ranges from $96,300.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Engineering
Facilities Engineer
Alpharetta, GA jobs
The Facilities Engineer is an integral part of the Facilities Team and has various roles and responsibilities. They are responsible for overseeing capital projects, maintaining the electronic drawing system, supporting validation activities, and reviewing and approving facilities and maintenance preventative maintenance documents. The Facilities Engineer is responsible for writing and executing engineering investigations, deviations and incidents and work closely with impacted departments. This role includes supervising staff, performing hands-on maintenance tasks, coordinating with contractors, and ensuring building compliance with safety, FDA, OSHA, and quality regulations and preventative maintenance schedules.
Key Duties and Responsibilities:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Oversee Facility operations of HVAC, plumbing, electrical, and other mechanical systems.
Develop and implement preventative facility maintenance schedules for all equipment and building systems.
Conduct routine inspections to identify, diagnose, and resolve facility issues.
Supervise and assign work to facilities technician(s) and external contractors; monitor work progress and quality.
Assign minor repairs and maintenance in plumbing, electrical, HVAC, carpentry, and general handyman tasks to Facility Technicians and/or collaborate with Maintenance to resolve matters.
Maintain records of building inspections, activities, and repairs.
Ensure all systems and equipment comply with safety codes, building regulations, and operational standards.
Manage department budgets; obtain estimates and approve cost-effective solutions.
Respond promptly to emergency repair needs to minimize downtime and disruptions.
Ensure that cosmetic and structural improvements, including painting, furniture repair, floor care, and general upkeep are done.
Consulted on office moves, installations, and space planning activities as needed.
Maintain a clean and orderly environment, including exterior areas such as parking lots and gutters.
Ensure that facility equipment and supplies are transported between facilities.
Support other departments with facility related needs and projects.
Foster a safe working environment by enforcing safety protocols and housekeeping practices.
Use and manage a digital work-order system to track facility projects, requests, and activities.
Collaborate with Engineering and Maintenance and other departments to address facility matters as needed to minimize the use of contractors
Lead engineering investigations into performance of site manufacturing, packaging, facilities and utilities systems, and development of proposals to optimize performance. These investigations can either be carried out internally, or by contractors.
Execution of engineering investigations into site requirements to meet business opportunities, regulatory requirements, etc. Development of proposals to meet site goals and objectives. These investigations can either be carried out internally, or by external contractors.
Development of site engineering procedures to ensure effective and compliant execution of engineering work on site.
Development of engineering documentation required by manufacturing and packaging operations, facilities, utilities, and/or new projects. This will include development of specifications, test protocols, procedures, etc.
Project management for new site projects. For large projects [generally those involving a third-party engineering contractor], this may include design guidance, review and approval, and liaison with site functions, as site engineering representative.
Provide Engineering assistance to Validation during protocol execution Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that actions with department and company culture.
Other duties as assigned.
Qualifications, Education, and Experience Required:
High school diploma or equivalent; technical training or certifications in HVAC, electrical, or plumbing preferred.
10+ years of facility/engineering/maintenance experience, with supervisory responsibilities.
Strong knowledge of HVAC, plumbing, electrical, landscaping, automation, management, and general building systems.
Familiarity with safety standards, building codes, and facility compliance requirements (ISO, FDA regulations).
Ability to read and interpret technical manuals, blueprints, and diagrams.
Strong organizational, troubleshooting, communication, and leadership skills.
Ability to analyze and resolve complex problems in terms of fundamental engineering and / or scientific principles.
Ability to apply engineering and / or scientific principles to the development of procedures, specifications and standards for systems and equipment new to the site.
Ability to execute, document and present investigations into engineering-related issues.
Ability to apply project management principles to new projects and plan, organize and execute such projects.
Knowledge of engineering aspects of pharmaceutical manufacturing facilities.
Understanding of the requirements for commissioning and qualification of systems.
Understanding of cGMP requirements for manufacturing.
Knowledge of computerized Facilities and Maintenance management systems.
Bilingual (English/Spanish) a plus.
Physical Demands:
Ability to sit, stand, walk, climb ladders, stoop, kneel, and lift up to 50 lbs.
You must be able to work on rooftops, above ceilings, and in tight spaces to inspect and repair equipment.
Vision requirements include close, distance, peripheral, and depth perception.
Language Skills:
English required, bilingual (Spanish) a plus.
Physical Demands:
This position is regularly active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day. The employee must frequently lift and/or move items over 50 pounds. Specific vision abilities required by this job includeclose vision, distancevision, color vision,peripheral vision, depth perception, and the ability to adjust focus.
Work Environment:
Non-temperature-controlled warehouse, non-temperature-controlled production floor,temperature-controlled office.
This position may require occasional evening or weekend work to address facility issues or emergencies.
Other Duties:
Please note this job description is not designed to coveror contain a comprehensive list of activities, duties or responsibilities that required the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
AAP/EEO Statement:
CHEMENCE provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Tech Services - Senior Associate Engineer
Washington, DC jobs
Use Your Power for Purpose
As a Senior Tech Ops Engineer, you will play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives.
The Sr Tech Ops Engineer provides strategic direction and technical expertise for site Commissioning and Qualification (C&Q) activities for equipment, utilities and facilities. To include execution of C&Q work for utilities, facilities and global applications as well as maintenance and execution of periodic performance qualification schedule and reviews. This role serves as a Center of Excellence, driving alignment with global and industry engineering standards. The engineer supports site critical programs related to C&Q while also supporting capital project execution and site-wide technical initiatives. The position plays a key role in shaping the site's technology roadmap, ensuring operational excellence, and fostering a self-sustaining technical work structure for the Focus Factory Manufacturing Technology teams.
What You Will Achieve
In this role, you will:
S/he acts as the SME for C&Q work for Utilities, Facilities and Equipment across the site. Individual must have knowledge and application experience of technical design reviews, commissioning and qualification for pharmaceutical systems.
S/he will be expected to work routinely with cross functional groups throughout the site for process improvements and implementation. S/he must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Person will be responsible for interfacing with auditors and presenting on site processes.
S/he organizes, coordinates and supports testing associated with the development of new process technologies and the support of new systems introductions. S/he works closely with site Quality and Engineering resources to ensure appropriate C&Q of site systems is achieved and maintained against procedures and industry guidance. S/he plans, generates, reviews and approves site technical reports, to include validation plans/protocols, design specs, Risk Assessments.
S/he will be expected to ensure site alignment to global procedures and work instructions related to C&Q work. Provide ongoing training, guidance and templates to support the technical teams within the Focus Factories.
S/he will be expected to confirm C&Q pre-requisites are met and supported by approved documentation in accordance with procedures and industry standards. Oversee and assist team members and contractor resources with their assigned projects. Support development and design of C&Q strategies, studies, draft and/or review project validation plans and documentation.
S/he to provide input in technology transfer, risk assessments, validation deviations and/or quality deviation investigations to identify root causes and define correction and/or preventive actions (CAPA). Author and/or review risk assessment documents. Review investigations, commitments, procedures, and batch records. Provide technical input and complete SME impact assessment to proposed change controls vetted for implementation. Participate in teams assembled to complete change control implementation for new and existing systems.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
Solid knowledge/understanding of C&Q strategies
Understanding of various pharmaceutical equipment, utility and facility systems, preferably related to sterile injectable operations.
Solid leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
Must be self-motivated and work with little direction
Good interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
An aptitude for understanding process technology and controls applications, decision making ability, and excellent oral and written communication skills are essential. Demonstrated ability to interact effectively with multiple levels of the organization. Candidate must possess flexibility to respond to changing conditions and priorities.
Understanding of global regulations on GMP processes.
Bonus Points If You Have (Preferred Requirements)
Technical writing experience.
Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices.
Working knowledge of Food and Drug Administration (FDA) Regulations/Guidance, and Good Manufacturing Practices (GMP).
Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
PHYSICAL/MENTAL REQUIREMENTS
Remains organized & positive in ambiguous and fast-paced, rapidly changing environment
Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
Ability to process complex information and make recommendations with incomplete data set
Ability to adjust work schedule to meet business needs - overtime, off shift, weekends.
Ability to travel
Able to stand for extended hours for test runs and performance monitoring of processes - will include working within special gowning for cleanroom access
Able to climb ladders/steps
Able to lift items of 25lbs
Strategic thinker for issue resolution
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Pfizer operates 24/7 across most of the business units. Employee must have the ability to work extended hours, holidays and/or weekends as needed. Limited travel may be required to support OEM equipment design reviews and/or Factory Acceptance Testing of new equipment. Employee will be expected to periodically work within clean room areas requiring special gowning.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Engineering
Lead Product Security Engineer (R&D Cytology)
San Diego, CA jobs
Marlborough, MA, United States San Diego, CA, United States Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a **Lead Product Security Engineer** and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market.
This is a hybrid role based out of either Marlborough, MA or San Diego, CA.
**Key responsibilities and applied experience required from a candidate:**
+ Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures.
+ Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices.
+ Support the creation and maintenance of security design documentation and architecture diagrams.
+ Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle.
+ Define security requirements and controls based on specific use cases and threat models.
+ Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety.
+ Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs.
+ Establish automated processes for vulnerability scanning and remediation
+ Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments.
+ Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process
+ Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems.
+ Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents.
+ Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports.
**Experiences that are nice to have:**
+ Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions.
+ Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA,
+ GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
+ Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability.
+ Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution.
**Minimum Requirements:**
+ Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent.
+ Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering
+ Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.)
+ Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences.
+ Skilled in working within cross-functional groups.
+ Skilled in performing Risk Assessment and Management plan
+ Skilled in writing design documentation and standard operating procedures.
+ Experience working in an FDA regulated environment is required.
+ Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
+ Strong verbal & written communication skills.
+ Familiarity with Windows OS and cloud-based solutions is required
+ Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team.
+ Proficiency in scripting and simple test automation (e.g., PowerShell, Python).
The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
**Why Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, **apply today!**
\#LI-RF1 #lead-level
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Lead Product Security Engineer (R&D Cytology)
Marlborough, MA jobs
Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a Lead Product Security Engineer and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market.
This is a hybrid role based out of either Marlborough, MA or San Diego, CA.
This position will operate as part of the broader Diagnostics team, which has additional members in San Diego, to create a cohesive cybersecurity strategy for the division.
Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures.
Participate in continuous improvement of our Secure by Design policies and procedures, ensuring adherence to security standards and best practices.
Support the creation and maintenance of security design documentation and architecture diagrams.
Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle.
Define security requirements and controls based on specific use cases and threat models.
Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety.
Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs.
Establish automated processes for vulnerability scanning and remediation
Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments.
Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions.
Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability.
Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process.
Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution.
Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems.
Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents.
Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports.
Required Education and Experience:
Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent.
Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering
Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.)
Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences.
Skilled in working within cross-functional groups.
Skilled in performing Risk Assessment and Management plan
Skilled in writing design documentation and standard operating procedures.
Experience working in an FDA regulated environment is required.
Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
Strong verbal & written communication skills.
Familiarity with Windows OS and cloud-based solutions is required
Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team.
Proficiency in scripting and simple test automation (e.g., PowerShell, Python).
The annualized base salary range for this role is $128,300 to $200,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, apply today!
#LI-RF1 #lead-level
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Auto-ApplyLead Product Security Engineer (R&D Cytology)
Marlborough, MA jobs
Marlborough, MA, United States San Diego, CA, United States Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a **Lead Product Security Engineer** and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market.
This is a hybrid role based out of either Marlborough, MA or San Diego, CA.
**Key responsibilities and applied experience required from a candidate:**
+ Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures.
+ Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices.
+ Support the creation and maintenance of security design documentation and architecture diagrams.
+ Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle.
+ Define security requirements and controls based on specific use cases and threat models.
+ Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety.
+ Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs.
+ Establish automated processes for vulnerability scanning and remediation
+ Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments.
+ Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process
+ Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems.
+ Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents.
+ Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports.
**Experiences that are nice to have:**
+ Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions.
+ Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA,
+ GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
+ Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability.
+ Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution.
**Minimum Requirements:**
+ Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent.
+ Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering
+ Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.)
+ Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences.
+ Skilled in working within cross-functional groups.
+ Skilled in performing Risk Assessment and Management plan
+ Skilled in writing design documentation and standard operating procedures.
+ Experience working in an FDA regulated environment is required.
+ Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities.
+ Strong verbal & written communication skills.
+ Familiarity with Windows OS and cloud-based solutions is required
+ Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team.
+ Proficiency in scripting and simple test automation (e.g., PowerShell, Python).
The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
**Why Hologic?**
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, **apply today!**
\#LI-RF1 #lead-level
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Staff Medical Device Engineer
San Diego, CA jobs
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
As a member of the Advanced Research & Technology (ART) Team you will support the evaluation of new technologies through testing, modeling, analysis, prototyping, and experimentation. Working as a member of a technology team, this engineer will collaborate and communicate with other engineers and scientists on the team as well as interface with technical personnel from other departments and vendors. This position offers a unique opportunity to have significant impact towards defining Dexcom's development roadmap and influencing the lives of millions of people within a small team of engineers.
Where you come in:
* Design, setup, plan, and perform electrical, mechanical, or related experiments in the lab
* Design, fabricate, document, and troubleshoot new test fixtures and equipment
* Improve and/or optimize existing test equipment, fixtures, and methods
* Support development of new or improved test methods simulating actual product use conditions
* Generate and execute test protocols leveraging statistical best practices, documenting the results
* Analyze experimental data to build statistically sound models and develop conclusions
* Provide design recommendations while also acknowledging potential tradeoffs of solutions
* Build and evaluate prototypes
What makes you successful:
* Comfortable working hands-on in a fast-paced environment
* Comfortable managing several parallel activities
* High Proficiency with engineering software tools for CAD (SolidWorks required)
* High Proficiency with statistical analysis (DOE, Gauge R&R, ANOVA, Power and Sample Size)
* Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things
* Strong interpersonal and teamwork skills
* Demonstrated written and verbal communication skills
* Familiarity with DMAIC problem solving techniques
* Familiarity with FEA tools (Abaqus preferred)
* Familiarity with JMP or Minitab (JMP preferred)
* Familiarity with programming (LabView preferred)
* Familiarity with image processing techniques
* Familiarity with control systems (actuators, pneumatics, sensors, etc.)
* Familiarity operating equipment within a machine shop (Mill, Lathe, etc.)
* Experience working within a regulated medical device environment
* Proficiency with Microsoft Office Products
* Basic skills or knowledge related to product, process, equipment, and fixture design, development and improvement
What you'll get:
* A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
* A full and comprehensive benefits program.
* Growth opportunities on a global scale.
* Access to career development through in-house learning programs and/or qualified tuition reimbursement.
* An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
* 0-5%
Experience and Education Requirements:
* Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8- 12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$128,600.00 - $214,400.00
Staff Medical Device Engineer
San Diego, CA jobs
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
As a member of the Advanced Research & Technology (ART) Team you will support the evaluation of new technologies through testing, modeling, analysis, prototyping, and experimentation. Working as a member of a technology team, this engineer will collaborate and communicate with other engineers and scientists on the team as well as interface with technical personnel from other departments and vendors. This position offers a unique opportunity to have significant impact towards defining Dexcom's development roadmap and influencing the lives of millions of people within a small team of engineers.
Where you come in:
Design, setup, plan, and perform electrical, mechanical, or related experiments in the lab
Design, fabricate, document, and troubleshoot new test fixtures and equipment
Improve and/or optimize existing test equipment, fixtures, and methods
Support development of new or improved test methods simulating actual product use conditions
Generate and execute test protocols leveraging statistical best practices, documenting the results
Analyze experimental data to build statistically sound models and develop conclusions
Provide design recommendations while also acknowledging potential tradeoffs of solutions
Build and evaluate prototypes
What makes you successful:
Comfortable working hands-on in a fast-paced environment
Comfortable managing several parallel activities
High Proficiency with engineering software tools for CAD (SolidWorks required)
High Proficiency with statistical analysis (DOE, Gauge R&R, ANOVA, Power and Sample Size)
Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things
Strong interpersonal and teamwork skills
Demonstrated written and verbal communication skills
Familiarity with DMAIC problem solving techniques
Familiarity with FEA tools (Abaqus preferred)
Familiarity with JMP or Minitab (JMP preferred)
Familiarity with programming (LabView preferred)
Familiarity with image processing techniques
Familiarity with control systems (actuators, pneumatics, sensors, etc.)
Familiarity operating equipment within a machine shop (Mill, Lathe, etc.)
Experience working within a regulated medical device environment
Proficiency with Microsoft Office Products
Basic skills or knowledge related to product, process, equipment, and fixture design, development and improvement
What you'll get:
A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
0-5%
Experience and Education Requirements:
• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8- 12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$128,600.00 - $214,400.00
Auto-ApplyPrincipal Product Development Engineer
Minnetonka, MN jobs
Working at Freudenberg: We will wow your world!
Responsibilities:
Anticipates business challenges and/or regulatory issues, reviews and recommends products/services and process improvements to the board of the business group
Looks beyond existing methodologies and the own discipline to define and resolve highly complex problems
Internal and external thought leader influencing change and advancement of the industry and/or profession
Recognized technical principal and internal thought leader in own area of responsibility w/in the business group
Significantly contributes to the development of the functional strategy (e.g. R&D, Manufacturing, Sales) of the business group
Requires broad and comprehensive expertise in theories, techniques and/or technologies within own field which have a broad impact on the business
Anticipates business and regulatory issues; recommends product process or service improvements
Oversees introduction of value-adding, technical solutions and leads/directs introduction of emerging technologies
Requires conceptual and innovative thinking to develop solutions
Impacts the direction and resource allocation for program, project or services; works within general functional policies and industry guidelines
Communicates highly complex ideas, anticipates potential objections and persuades others at senior management levels to adopt a different point of view
Lead others to solve unique and highly complex problems which have a significant impact on innovation and a broad impact on the business.
Qualifications:
12 years of Medical Device design & development experience.
Bachelor of Science in Mechanical, Biomedical Engineering, or related discipline. Master's degree preferred.
21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 ISO 10993 and IEC 62366.
3D solid modelling (e.g. SolidWorks or related software).
Hands-on experience with machining and 3D prototyping methods preferred.
Knowledge of silicone and plastic molding preferred.
Good communication & interpersonal skills.
Excellent mechanical, analytical & problem-solving skills.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg Medical LLC
Auto-ApplyField Application Engineer
San Jose, CA jobs
Responsible for supporting the adoption and deployment of comapny's cutting-edge CXL-based computational memory solutions. Major responsibilities include engaging with customers and partners to understand their technical requirements and ensuring seamless integration and
exceptional performance of company's products.
Key Responsibilities
- Customer/Partner Engagement CPU and Server Validation Process management
o Serve as the primary technical contact for customers, developing and executing
comprehensive device validation plans for company's CXL computational memory
solutions.
o Collaborate with customers to understand their system architectures, workloads,
and challenges, delivering tailored recommendations for seamless integration and
optimal performance.
o Manage test equipment setup, experimental planning, results analysis, and the end-
to-end validation process at customer sites, ensuring rapid adoption and high
reliability of company's devices.
- Product Support and Training
o Conduct system-level debugging, performance tuning, and root cause analysis for
customer-reported issues.
o Develop and deliver technical presentations, training sessions, and documentation to
help customers effectively utilize company's computational memory.
o Assist in the creation of application notes, user guides, and best practices
documentation.
- Cross-functional Leadership and Technical Sensing
o Work closely with company's engineering and product development teams to provide
feedback on customer requirements, feature requests, and potential product
improvements.
o Partner with the marketing and business development teams to support go-to-
market strategies, including technical demos and proof-of-concept projects.
o Stay updated on emerging trends in computing systems (e.g. CXL, CPU, memory, and
near data processing) technologies to proactively address market demands and
challenges.
Key Requirement
- Minimum Qualifications:
o Bachelors or Masters degree in Engineering, Computer Science, or a related field
(or equivalent experience).
o At least 10 years of experience in technical and commercial roles, preferably within
CXL, Near-Data Processing, AI, or memory industries.
o Demonstrated ability to thrive in team-oriented environments while also working
independently, especially in high-pressure or ambiguous situations.
o Exceptional leadership, communication (both written and oral), and interpersonal
skills.
o Strong organizational and analytical abilities.
o Effective problem-solving and issue resolution skills.
o Willingness and ability to travel regularly to South Korea and occasionally to other
countries.
- Preferred Qualifications:
o Experience in field application engineering, technical marketing, or technical
specialist roles.
o Comprehensive knowledge of both hardware and software in AI, including
technical, commercial, and product/application expertise.
Associate Principal IT Product Lead - Data Engineering & Architecture
Alameda, CA jobs
SUMMARY/JOB PURPOSE:
The Associate Principal IT Product Lead - Data Engineering and Architecture will oversee Data Strategy, Architecture, and Engineering, key to Exelixis's success and ambition in launching innovative medicines to patients. This role drives strategy, execution, and operational excellence of the data ecosystem, aligning with business goals, data governance, and value delivery. Operating within a product-centric operating model, they will define roadmaps, foster collaboration, and lead agile teams to deliver impactful solutions that accelerate drug discovery, development, and commercialization.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Product Strategy & Roadmap (Product-Centric Focus):
Support the development and execution of the vision, strategy, and roadmap for Clinical and Operational data engineering and governance.
Partner with senior product leads and business stakeholders (e.g., R&D, Clinical, Supply Chain, G&A,) to gather insights, understand user needs, and translate them into clear product requirements and user stories.
Design and implement scalable data architectures using AWS, Databricks, and modern patterns like data mesh and Lakehouse.
Contribute to market research, competitive analysis, and technology assessments to inform product planning and identify innovation opportunities.
Evaluate business impact, technical feasibility, compliance needs, and resource constraints to assist in prioritizing product initiatives.
Collaborate with engineering and data governance teams to ensure data architecture follows FAIR principles, is secure, and meets enterprise standards.
Product Development & Delivery (Agile/Product Team Leadership):
Support the Principal Product Lead in mentoring Business Analysts and other team members, encouraging a culture of ownership, innovation, and continuous improvement.
Contribute to managing the product lifecycle from ideation through launch and post-launch optimization, applying Agile methodologies (e.g., Scrum, Kanban) to ensure efficient delivery.
Assist in defining clear user stories, acceptance criteria, and product specifications that align with the product vision and business objectives.
Collaborate with engineering, architecture, and quality assurance teams to ensure the timely delivery of scalable, secure, high-quality, and governed data products.
Coordinate with external vendors and service providers to support alignment on product roadmaps and delivery operations.
Promote user-centric design by incorporating user research, usability testing, and feedback into product enhancements.
Translate business needs into scalable data solutions across clinical, supply chain, and operations domains.
Implement data governance frameworks for quality, lineage, and lifecycle management.
Stakeholder Management & Cross-Functional Collaboration:
Act as a key liaison between IT and business functions, helping to translate technical concepts into business language and vice versa.
Build collaborative relationships with stakeholders to support alignment of product vision, priorities, and outcomes.
Facilitate communication and coordination across product, business, and IT teams to support effective decision-making.
Represent the product team in cross-functional discussions and contribute to strategic initiatives as needed.
Operational Excellence, Quality & Compliance:
Support efforts to maintain the operational stability, performance, and security of data solutions in collaboration with IT operations and infrastructure teams.
Assist in managing vendor relationships and third-party software solutions that support the data and analytics portfolio.
Help ensure compliance with regulatory requirements (e.g., GxP, HIPAA, GDPR) and internal quality and security standards across product releases.
Contribute to quality assurance processes to ensure product releases meet defined standards.
Actively contribute to the Implementation and maintenance of robust data management & AI practices to protect sensitive information and ensure its accuracy and reliability.
Track and report on key performance indicators (KPIs) to assess product success, adoption, and business impact, and support continuous improvement efforts.
SUPERVISORY RESPONSIBILITIES:
No supervisory responsibilities.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
Bachelor's degree in related discipline and 11 years of related experience; or
Master's degree in mathematics or statistics or engineering, and 9 years of related experience.
PhD degree in a related discipline and 5 years of related experience; or
Equivalent combination of education and experience.
Experience/The Ideal Candidate will have:
Minimum of 6 years of experience supporting Enterprise IT enabling business functions.
Minimum of 8+ years of progressive experience in IT, with at least 6+ years in a leadership role focused on data architecture and engineering in a life science or pharmaceutical industry.
Proven experience leading product development teams in an agile/product-centric operating model is essential.
Strong understanding of the drug discovery or clinical development, or commercialization lifecycle within a pharmaceutical or biotechnology company.
Deep understanding of clinical and operational data in a life sciences or Pharma company, including experience creating physical and logical data models for analytics and data science teams that follow data standards.
Extensive experience in creating resilient data architectures on cloud platforms like AWS and Azure, integrating advanced data management solutions such as Databricks and Snowflake.
Experience with regulatory frameworks and compliance in a GxP environment.
Knowledge / Skills:
Exceptional leadership and team-building skills, with the ability to inspire and motivate diverse teams.
Strong strategic thinking and problem-solving abilities, with a data-driven approach to decision-making.
Excellent communication, presentation, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization.
Deep understanding of product management methodologies (e.g., Agile, Scrum, Kanban) and product lifecycle management.
Solid technical acumen with the ability to understand complex IT architectures and development processes.
Apply hands-on expertise with tools like Databricks, DBT, Glue, Kafka, Airflow, S3, Delta Lake, Redshift, Unity Catalog, and Atlan.
Develop with Spark, Python, SQL, and REST APIs using cloud-native services.
Ability to manage multiple priorities in a fast-paced, dynamic environment.
Occasional travel may be required to other company sites, conferences, or vendor locations.
#LI-EZ1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $167,000 - $237,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyManufacturing Engineer (Engineering)
Louisville, KY jobs
At Whip Mix, innovation isn't just what we do-it's who we are. For over a century, we've been a trusted partner to dental professionals worldwide. From designing and manufacturing cutting-edge digital solutions to tried-and-true lab essentials, we bring craftsmanship, technology, and customer care together in one place.
We're proud to be a family-owned, Louisville-based company with a global reach, serving dental labs, universities, and clinicians across more than 80 countries. Our mission? To combine quality and creativity with a service-first mindset that makes a real difference in people's lives. If you're looking to join a team where tradition meets innovation, and where every day brings new opportunities to grow, Whip Mix is the place for you.
Job Skills / Requirements
We are looking for a Manufacturing Engineer who thrives on solving complex problems, optimizing production processes, and turning great ideas into real-world results to join our team. You will design, develop, and improve manufacturing processes and tooling to increase efficiency, quality, and safety across production lines. This hands-on role is ideal from an engineer who enjoys collaborating across teams, driving continuous improvement, and bringing ideas from concept to completion.
What you'll be doing:
Design, fabricate, and test prototypes, parts, tooling and fixtures using CAD software (SolidWorks or similar).
Conduct validation studies and analyzed data to optimize manufacturing processes.
Identify and implement continuous improvement opportunities to enhance product quality and efficiency.
Support day-to-day manufacturing operations by resolving process and tooling issues.
Collaborate with purchasing, quality and production to address vendor or material concerns.
Create and update BOM's, routings, and work instructions is ERP/MRP systems.
Participate in root cause analyses, material review board activities, and inspection criteria updates.
Provide training and technical guidance to production staff on new or updated processes.
What you'll bring to the table:
Bachelor's degree in engineering or related field required.
3+ years of experience in manufacturing or process engineering preferred.
Proficient in SolidWorks or similar CAD software.
Knowledge of GD&T, lean manufacturing, ISO 13485 and GMP standards.
Experience with ERP/MRP systems for BOMs and change management.
Understanding machining, molding, assembly, and 3D printing processes.
What's in it for you:
Comprehensive health, dental, and vision benefits
401k plan with a company contribution
Time off! PTO, Sick Time, paid holidays plus a paid wellness day yearly to take care of things that keep you healthy
A collaborative team environment where ideas are encouraged, not buried in red tape.
The opportunity to design, build, test, and improve every day within a company that values innovation and craftsmanship.
Additional Information / Benefits
Benefits: Medical Insurance, Life Insurance, Dental Insurance, Vision Insurance, Paid Vacation, Paid Sick Days, Paid Holidays, 401K/403b Plan
This is a Full-Time position
Medical Device Engineer
Austell, GA jobs
Job Details Experienced AUSTELL, GA Full Time 4 Year Degree None DayDescription
We are seeking a Medical Device Engineer with direct, hands-on experience in Class I and Class II medical device development and sustaining engineering. This role is critical to maintaining the safety, compliance, and performance of our existing product portfolio while contributing to early-stage innovation and concept development.
The ideal candidate will have a minimum of 3 years of industry experience in a regulated medical device environment, with a strong foundation in design controls, risk management, and supplier collaboration. This is not an entry-level role.
What Makes This Role Unique
Be the technical steward for marketed products, ensuring ongoing compliance with FDA and ISO standards.
Influence future product directions through early-stage concept development and unmet need identification.
Collaborate with external consultants and global suppliers, managing deliverables and ensuring alignment with internal standards.
Support internal capability building, including design control education and process improvement.
Key Responsibilities
Lead sustaining engineering activities for Class I and II medical devices.
Remediate and maintain risk management files in accordance with ISO 14971 and FDA 21 CFR Part 820.
Develop and maintain product specifications, technical documentation, and design history files.
Review and manage engineering change requests (ECRs/ECOs).
Collaborate with suppliers to ensure design and quality alignment.
Manage and coordinate work with external consultants and contractors.
Support and educate teams on design control processes.
Develop, execute, and review testing protocols, validation plans, and statistical sampling plans.
Contribute to early-stage product development, including concept creation and feasibility assessments.
Qualifications
Required Qualifications
Minimum 3 years of experience in medical device engineering, specifically with Class I and/or Class II devices.
At least 3 years of hands-on experience in product development, including concept creation, design iteration, and documentation within a regulated medical device environment.
Proven experience in design control, risk management, and sustaining engineering.
Strong knowledge of ISO 13485, ISO 14971, and FDA QSR (21 CFR Part 820).
Experience with test method development, validation, statistical analysis, and sampling plans.
Demonstrated ability to manage contractors and suppliers effectively.
Excellent written and verbal communication skills.
Ability to work cross-functionally in a compliance-driven environment.
Preferred Qualifications
Experience with human factors, usability engineering, and ergonomics.
Familiarity with early-stage product development and innovation planning.
Advanced degree in engineering or related field is a plus.
BioProcess Engineer
Racine, WI jobs
About Us Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics. A Brief Overview
Contributes to equipment projects and manufacturing process improvements. Provides insight and contributes to production reliability. Participates as a team member for technical operations sections of product development projects, including scale-up and production line design. Leads process development and equipment projects while maintaining schedules and meeting budgets. Success is measured through implementation of projects that meet desired outcome, budget, timeline, and manufacturing goals. What You Will Do
Process design Coordinates implementation of manufacturing equipment, process automation, process expansions, and new initiatives. Includes project budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.
Process sustenance Identify production interruptions and establish risk mitigations. Troubleshoot equipment and processing issues in support of production goals. Determine calibration and maintenance needs of new equipment.
Process evaluation Establish new product costs, develop and implement necessary SOP's, and establish processing, packaging and test specifications for products and equipment. Identify process inefficiencies and implement strategies, including automation and scale-up, to identified areas.
Maintain Budgets Create and maintain project time lines and plans, accelerating where possible. Create project and/or capital budgets in cooperation with management to meet department budgets.
Minimum Requirements
Bachelor of Science (B.S.) in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Physical Science.
Less than 1 year of relevant work experience.
Preferred Qualifications
Master of Science (M.S. or M.Sc.) in Engineering, Business, or related discipline.
3+ years of medical device or pharmaceutical process experience or similar experience in a regulated industry.
Technical & Functional Skills
Familiar with ISO 13485 / FDA QSR / GMP / Other medical industry regulations.
Ability to formulate program strategy, budgets and timelines.
Solidworks and/or AutoCAD.
Six Sigma Methodologies.
Statistical Analysis.
Strong technical and problem-solving skills.
Ability to communicate and write effectively.
Benefits:
Comprehensive Medical, Dental, and Vision plans
20 days of Paid Time Off
15 paid holidays
Paid Sick Leave
Paid Parental Leave
401(k)
Employee bonuses
And more!
Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.