Device Quality Engineer - Device Risk Management and Surveillance Excellence
Sanofi
August 13, 2026
Remote friendly (Cambridge, MA)
United States
$90,000 - $130,000 USD yearly
Operations
Main Responsibilities:
- Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes across Sanofi as the global process owner.
- Ensure SOPs align with applicable regulations and industry standards while driving continuous improvement.
- Analyze post-market data to identify trends, multi-site impacts, and implement corrective actions.
- Ensure Device Risk Management Files accurately reflect current product risks and remain updated throughout the product lifecycle; provide guidance on harmonized risk management approaches aligned with ISO 14971.
- Develop new tools, comprehensive training programs, and mentor colleagues on process execution, best practices, and risk management methodologies.
- Ensure project teams use appropriate risk analysis tools (FMEAs, PHA) and facilitate dFMEA moderation sessions.
- Author and maintain post-market surveillance deliverables throughout the product lifecycle.
- Support Design Controls implementation for new product development and design changes, including Design History File maintenance.
- Partner with quality, compliance, development, and manufacturing teams to ensure transparency, coordination, and patient safety actions.
Qualifications (Basic):
- BS degree in Engineering, Business, Life Sciences, or related science discipline.
- MS degree is a plus.
- 5+ years of medical device industry experience.
- 3+ years of relevant experience in Risk Management and Post-Market Surveillance for medical devices and/or drug-device combination products.
- Deep knowledge of ISO 14971; knowledge of ISO 13485, MDR (2017/745), and 21 CFR 820; ability to collaborate cross-functionally and apply problem-solving methodologies.
- Complaint management experience is a plus.
- English required (written and oral); French or German is a plus.
Technical Skills:
- ISO 14971 Risk Management; Post-Market Surveillance (PMS); FMEA / risk analysis tools; Regulatory compliance (MDR / 21 CFR 820); Design Controls & DHF management.
Soft Skills:
- Cross-functional collaboration, strategic thinking, attention to detail, stakeholder influence, mentoring & knowledge transfer.
- Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes across Sanofi as the global process owner.
- Ensure SOPs align with applicable regulations and industry standards while driving continuous improvement.
- Analyze post-market data to identify trends, multi-site impacts, and implement corrective actions.
- Ensure Device Risk Management Files accurately reflect current product risks and remain updated throughout the product lifecycle; provide guidance on harmonized risk management approaches aligned with ISO 14971.
- Develop new tools, comprehensive training programs, and mentor colleagues on process execution, best practices, and risk management methodologies.
- Ensure project teams use appropriate risk analysis tools (FMEAs, PHA) and facilitate dFMEA moderation sessions.
- Author and maintain post-market surveillance deliverables throughout the product lifecycle.
- Support Design Controls implementation for new product development and design changes, including Design History File maintenance.
- Partner with quality, compliance, development, and manufacturing teams to ensure transparency, coordination, and patient safety actions.
Qualifications (Basic):
- BS degree in Engineering, Business, Life Sciences, or related science discipline.
- MS degree is a plus.
- 5+ years of medical device industry experience.
- 3+ years of relevant experience in Risk Management and Post-Market Surveillance for medical devices and/or drug-device combination products.
- Deep knowledge of ISO 14971; knowledge of ISO 13485, MDR (2017/745), and 21 CFR 820; ability to collaborate cross-functionally and apply problem-solving methodologies.
- Complaint management experience is a plus.
- English required (written and oral); French or German is a plus.
Technical Skills:
- ISO 14971 Risk Management; Post-Market Surveillance (PMS); FMEA / risk analysis tools; Regulatory compliance (MDR / 21 CFR 820); Design Controls & DHF management.
Soft Skills:
- Cross-functional collaboration, strategic thinking, attention to detail, stakeholder influence, mentoring & knowledge transfer.