Device Quality Engineer - Device Risk Management and Surveillance Excellence

Device Quality Engineer – Device Risk Management & Surveillance Excellence

Location:

Cambridge, MA

As Device Quality Engineer within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance, 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 and implement corrective actions.
• Maintain accurate Device Risk Management Files, updated throughout the product lifecycle.
• Provide guidance on harmonized risk management approaches aligned with ISO 14971 across all development and lifecycle programs.
• Develop tools, 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.
• Strong collaboration skills with peers, stakeholders and partners across the organization; proficiency in problem‑solving methodologies.
• Deep knowledge of ISO 14971; knowledge of ISO 13485, MDR (2017/745) and 21 CFR 820.
• Experience in complaint management is a plus.
• Languages:
  
  Mandatory English (written and oral) management;
  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

• Supportive, future‑focused team.
• Opportunities for career growth domestically or internationally.
• Thoughtful rewards package that recognizes your contribution and amplifies your impact.
• Health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks gender‑neutral parental leave.
• Contributing to cutting‑edge technology and resilient global supply.
• Leveraging digital, data, and AI‑driven innovation at speed and scale.
• Transforming lives worldwide by delivering life‑changing treatments anywhere, anytime.

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, affectional or sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.