Sr. Device Engineer
Pfizer
August 20, 2026
Remote friendly (Parsippany, NJ)
United States
Operations
What You Will Achieve
- Be responsible for device lifecycle management of on-market medical devices and combination products.
- Develop change management technical impact assessments, design/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 avoid adverse patient/user impact and maintain device design integrity.
- Liaison between GT&E Device Engineering Lifecycle Management (DELCM), internal production sites, Regulatory, and Quality.
- Lead design change projects per 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 disposition of Non-Conforming Reports and qualification of material/processes/changes to meet reliability requirements (with guidance/supervision).
- Ensure design controls are documented per internal procedures.
- Establish/review specifications/requirements for components, products, and processes (with guidance/supervision).
- Support CAPA and Complaint investigations, as appropriate.
Here Is What You Need (Minimum Requirements)
- Bachelor’s + 2 years; OR Master’s + 0+ years; OR Associate’s + 6 years; OR High school + 8 years relevant experience.
- Knowledge/experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
- Experience analyzing patient/user impact.
- Practical knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and related standards.
- Critical thinking and problem-solving; ability to work independently and in a fast-paced team.
- Working knowledge of statistical methods for data analysis.
Bonus Points (Preferred Requirements)
- Relevant pharmaceutical experience.
- Continuous improvement/Statistical Process Control (DMAIC, Six Sigma).
- Package performance testing equipment/methods; regional compendia testing requirements.
- Excellent communication/interpersonal skills; strong organization and attention to detail.
- Leadership and mentoring; experience using AI tools (e.g., ChatGPT, Microsoft Copilot) responsibly for problem solving.
Physical/Mental Requirements
- Office-based; support virtual teams via Webex and phone; flexibility across time zones.
Travel
- Up to 20%.
- Be responsible for device lifecycle management of on-market medical devices and combination products.
- Develop change management technical impact assessments, design/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 avoid adverse patient/user impact and maintain device design integrity.
- Liaison between GT&E Device Engineering Lifecycle Management (DELCM), internal production sites, Regulatory, and Quality.
- Lead design change projects per 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 disposition of Non-Conforming Reports and qualification of material/processes/changes to meet reliability requirements (with guidance/supervision).
- Ensure design controls are documented per internal procedures.
- Establish/review specifications/requirements for components, products, and processes (with guidance/supervision).
- Support CAPA and Complaint investigations, as appropriate.
Here Is What You Need (Minimum Requirements)
- Bachelor’s + 2 years; OR Master’s + 0+ years; OR Associate’s + 6 years; OR High school + 8 years relevant experience.
- Knowledge/experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
- Experience analyzing patient/user impact.
- Practical knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and related standards.
- Critical thinking and problem-solving; ability to work independently and in a fast-paced team.
- Working knowledge of statistical methods for data analysis.
Bonus Points (Preferred Requirements)
- Relevant pharmaceutical experience.
- Continuous improvement/Statistical Process Control (DMAIC, Six Sigma).
- Package performance testing equipment/methods; regional compendia testing requirements.
- Excellent communication/interpersonal skills; strong organization and attention to detail.
- Leadership and mentoring; experience using AI tools (e.g., ChatGPT, Microsoft Copilot) responsibly for problem solving.
Physical/Mental Requirements
- Office-based; support virtual teams via Webex and phone; flexibility across time zones.
Travel
- Up to 20%.