Design Quality engineer
Katalyst CRO · Plymouth, MN · 3 mo ago
On-siteQuality AssuranceContract
Responsible Activities
- Ensure 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
- Experience in DFMEA / risk analysis
- Skill in requirement management tools (DOORS, Jama, etc.)
- Knowledge of V&V execution and review
- Mandatory: ISO 13485, ISO 14971
- PREFERRED: IEC 60601 (electrical safety), IEC 62304 (software lifecycle), IEC 62366 (usability)
- Strong systems thinking
- Ability to identify design gaps early
- Ability to drive risk-based decisions