Device Quality Engineer - Device Risk Management and Surveillance Excellence

Device Quality Engineer – Device Risk Management and Surveillance Excellence

Location:

Cambridge, MA

As Device Quality Engineer - Device Risk Management and Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance. You are accountable for maintaining and continuously improving 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.

You will deliver expert quality support for risk management and post‑market surveillance activities across the development pipeline and post‑launch lifecycle management. The role involves collaborating with cross‑functional teams and external stakeholders to ensure expert evaluations on patient safety and compliance matters.

• 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 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, comprehensive training programs and mentor colleagues on process execution, best practices, and risk management methodologies.
• Ensure project teams utilize 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.

• 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.
• Ability to collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.
• Knowledge in problem‑solving methodologies; deep knowledge of ISO 14971.
• Knowledge of ISO 13485, MDR (2017/745) and 21 CFR 820.
• Experience in complaint management a plus.
• Languages:
  
  Mandatory English;
  French or German are a plus.

• ISO 14971 Risk Management
• Post‑Market Surveillance (PMS)
• FMEA / Risk Analysis Tools
• Regulatory Compliance (MDR / 21 CFR 820)
• Design Controls & DHF Management

• Cross‑functional Collaboration
• Strategic Thinking
• Attention to Detail
• Stakeholder Influence
• Mentoring & Knowledge Transfer

Salary range: $90,000.00 - $. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs.

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, domestic partnership or civil union status; sex, gender, gender identity or expression; sexual orientation; disability; veteran or military status; or liability for military status;

domestic violence victim status; atypical cellular or blood trait; genetic information; or any characteristic protected by law.