Sr. Device Engineer

Pfizer • Parsippany, NJ

4d • Hybrid

About The Position

At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. In this role, you will: Be responsible for device lifecycle management of on-market medical devices and combination products. Develop change management technical impact assessments, design and development plans, risk management and design verification plans, test methods and data analysis. Lead device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and to ensure device design integrity is maintained Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleagues Lead design change projects according to internal procedures, track progress, and communicate status to group leadership Establish experimental protocols, conduct experiments, analyze results Lead technical execution of Design History File (DHF) updates Establish and maintain relationships with internal production site colleagues Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material / processes / changes to assure reliability requirements are met, with guidance and supervision. Ensure the design controls are documented in accordance with internal procedures. Establish and review specifications / requirements for components, products and processes, with guidance and supervision. Support CAPA and Complaint investigations, as appropriate

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.
• Demonstrated knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products
• Experience analyzing patient/user impact
• Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards
• Critical thinking, and problem-solving skills
• An ability to work independently as well as a member of a team in a fast-paced environment
• Working knowledge of statistical methods for data analysis
• Permanent work authorization in the United States.

Nice To Haves

• Relevant pharmaceutical experience
• Proficiency in continuous improvement and Statistical Process Control methodologies, such as DMAIC and Six Sigma
• Familiarity with a wide range of package performance testing equipment and methods
• Understanding of regional pharmaceutical compendia testing requirements
• Excellent communication and interpersonal skills
• Strong organizational skills and attention to detail
• Demonstrated leadership capabilities and mentoring skills
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Responsibilities

• Be responsible for device lifecycle management of on-market medical devices and combination products.
• Develop change management technical impact assessments, design and development plans, risk management and design verification plans, test methods and data analysis.
• Lead device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and to ensure device design integrity is maintained
• Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleagues
• Lead design change projects according to internal procedures, track progress, and communicate status to group leadership
• Establish experimental protocols, conduct experiments, analyze results
• Lead technical execution of Design History File (DHF) updates
• Establish and maintain relationships with internal production site colleagues
• Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material / processes / changes to assure reliability requirements are met, with guidance and supervision.
• Ensure the design controls are documented in accordance with internal procedures.
• Establish and review specifications / requirements for components, products and processes, with guidance and supervision.
• Support CAPA and Complaint investigations, as appropriate

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior