Design Quality engineer

Katalyst Talent Agency
Cambridge, MA, United States
19 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours

Tech stack

Systems Engineering Failure Mode Effects Analysis Imaging Technology Software Engineering Jama (Software)

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.

Requirements

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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