Device Quality Engineer - Device Risk Management and Surveillance Excellence

Job Title

Device Quality Engineer – Device Risk Management and Surveillance Excellence

Cambridge, MA

The Device Quality Engineer leads global processes for patient safety and regulatory compliance. The role maintains and continuously improves Device Risk Management, Clinical Evaluation, and Post‑Market Surveillance processes, ensuring medical devices and drug‑device combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle.

• Lead Device Risk Management, Clinical Evaluation, and Post‑Market Surveillance processes as the global process owner.
• Ensure SOPs align with applicable regulations and industry standards while driving continuous improvement initiatives.
• 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 across all development and lifecycle management programs.
• Develop new tools, training programs, and mentor colleagues on process execution, best practices, and risk‑management methodologies.
• Ensure project teams use appropriate risk analysis tools (FMEAs, PHAs) 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.

• Bachelor’s degree in Engineering, Business, Life Sciences, or related science discipline (Master’s degree is a plus).
• 5+ years of experience in the medical device industry.
• 3+ years of experience in Risk Management and Post‑Market Surveillance for medical devices and/or drug‑device combination products.
• Proficiency in ISO 14971
  , ISO 13485, MDR (2017/745), and 21
  
  CFR
  820.
• Experience with complaint management a plus.
• Languages:
  
  Written and oral English is mandatory;
  French or German are a plus.
• Technical skills:
  Risk‑management tools (FMEA, PHAs), post‑market surveillance, regulatory compliance, Design Controls & DHF management.
• Soft skills:
  
  Cross‑functional collaboration, strategic thinking, attention to detail, stakeholder influence, mentoring & knowledge transfer.

Competitive salary range: $90,000–$130,000. Includes high‑quality health care, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, gender identity, sexual orientation, or disability.