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Design Quality engineer

Job

Katalyst Healthcares & Life Sciences

Cambridge, MA (In Person)

Full-Time

Posted 6 days ago (Updated 5 hours ago) • Actively hiring

Expires 6/23/2026

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Job Description

Design Quality engineer Katalyst Healthcares & Life Sciences - 4.0 Cambridge, MA Job Details 15 hours ago Qualifications ISO standards Regulatory compliance Design failure mode and effects analysis (DFMEA) Risk analysis Systems engineering Requirements management Design controls Engineering validation Product lifecycle management
Full Job Description 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

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