Design Quality engineer (Somerville)

Part-time

Katalyst HealthCares & Life Sciences

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 Requirement:
Strong understanding of: Design controls & product lifecycle
Systems engineering Experience in:
DFMEA / risk analysis
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

Apply

Vacancy posted 9 hours ago

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