Design Quality engineer
Katalyst CRO · Cambridge, MA · 1 mo ago
On-siteQuality AssuranceFull-time
Responsibilities
- 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.
Requirements
- Strong understanding of: Design controls & product lifecycle Systems engineering
- Experience in DFMEA / risk analysis
- Skill Requirement management tools (DOORS, Jama, etc.)
- V&V execution and review
- Regulatory & Standards Knowledge Mandatory: ISO 13485 ISO 14971 Preferred: IEC 60601 (electrical safety) IEC 62304 (software lifecycle) IEC 62366 (usability)
- Ultrasound / Imaging Domain (Preferred)
- Strong systems thinking
- Ability to: Identify design gaps early Drive risk-based decisions