More jobs:
Design Quality engineer
Job in
Plymouth, Hennepin County, Minnesota, USA
Listed on 2026-06-18
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-06-18
Job specializations:
-
Engineering
Quality Engineering, Systems Engineer
Job Description & How to Apply Below
Job Description
Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices, with a strong preference for ultrasound/imaging systems.
Skill Requirements- Strong understanding of:
Design controls & product lifecycle - Systems engineering
- DFMEA / risk analysis
- Requirement management tools (DOORS, Jama, etc.)
- V&V execution and review
- Regulatory & Standards Knowledge
- ISO 13485
- ISO 14971
- IEC 60601 (electrical safety)
- IEC 62304 (software lifecycle)
- IEC 62366 (usability)
Strong systems thinking Ability to:
- Identify design gaps early
- Drive risk-based decisions
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