Design Quality engineer
Katalyst Talent Agency
Plymouth, United States of America
yesterday
Role details
Contract type
Permanent contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
EnglishJob location
Plymouth, United States of America
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
Do you have experience in Systems engineering?, 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