Risk Management Quality Engineer I - New Product Development (Surgical)
Medtronic · North Haven, CT +2 more
QualityFull-time$66k–$100kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Medtronic seeks a Risk Management Quality Engineer for surgical product development, responsible for establishing risk management strategies, conducting hazard analyses, and ensuring regulatory compliance throughout the medical device lifecycle. The role is onsite 4 days weekly across three U.S. locations.
What they're looking for
- Bachelor's degree in engineering or related technical field
- Experience in medical devices, pharmaceuticals, or combination products
- Knowledge of medical device risk management standards such as ISO 14971
- Background in quality engineering, risk management, or systems engineering
- Familiarity with design controls and FDA/international regulatory requirements
- Strong written and verbal communication skills
What you'll be doing
- Develop and maintain risk management strategies, plans, and comprehensive risk management files
- Lead hazard analyses, DFMEAs, and design reviews to identify and control potential risks
- Analyze product complaints and field issues to prevent recurrence through root cause analysis
- Ensure traceability between risk assessments, design requirements, and regulatory compliance
- Develop and manage post-market surveillance plans to monitor product safety and performance
Privacy & handoff
This role links to Medtronic's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.