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Design Quality engineer
Job in
Cambridge, Middlesex County, Massachusetts, 02141, USA
Listed on 2026-07-01
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
Job Title
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 RequirementStrong 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
MandatoryISO 13485 ISO 14971
PreferredIEC 60601 (electrical safety) IEC 62304 (software lifecycle) IEC 62366 (usability) Ultrasound / Imaging Domain (Preferred)
Strong Systems Thinking Ability ToIdentify design gaps early Drive risk-based decisions
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