Sr. Device Engineer

Pfizer • Kalamazoo, MI

4d • Onsite

About The Position

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you will help bring medicines to the world even faster by imagining what’s possible and taking action. In this role, you will: 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. Ensure the design controls are documented in accordance with internal procedures. 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. As part of these changes, the updates may require supporting as Design Authority and/or Subject Matter Expert. Lead technical execution of Design History File (DHF) updates. Establish experimental protocols, conduct experiments, analyze results. Establish and review specifications / requirements for components, products and processes, with guidance and supervision. Support CAPA and Complaint investigations, as appropriate. Support design change projects according to internal procedures, track progress, and communicate status to group leadership. Liaison between various groups supporting post market changes and internal production sites to ensure alignment on changes as well as ensure awareness of changes; team members included but not limited to Regulatory, Quality colleagues, Commercial, Production, etc. 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.

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
• Prior experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality.
• Strong knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
• Experience analyzing patient/user impact.
• Experience in a GMP regulated industry.
• 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
• Experience with Computer Aided Design (CAD) software.

Nice To Haves

• Experience in the pharmaceutical or biotechnology industry
• Familiarity with Good Manufacturing Practices (GMP)
• Experience with statistical software (e.g., Minitab, JMP)
• Ability to lead cross-functional teams
• Strong organizational skills
• Adaptability and flexibility in a dynamic work environment
• Ability to mentor and develop junior team members
• 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

• 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.
• Ensure the design controls are documented in accordance with internal procedures.
• 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.
• Lead technical execution of Design History File (DHF) updates.
• Establish experimental protocols, conduct experiments, analyze results.
• Establish and review specifications / requirements for components, products and processes, with guidance and supervision.
• Support CAPA and Complaint investigations, as appropriate.
• Support design change projects according to internal procedures, track progress, and communicate status to group leadership.
• Liaison between various groups supporting post market changes and internal production sites to ensure alignment on changes as well as ensure awareness of changes; team members included but not limited to Regulatory, Quality colleagues, Commercial, Production, etc.
• 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.

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