KC
Design Quality engineer
Accepting applicationsKatalyst CRO · Cambridge, MA
Full-Time Associate ai
Posted
19 May
Category
Verification
Experience
Associate
Country
UK
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
Show more Show less
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
Show more Show less
Similar Jobs
M
Sr Design Verification Engineer, HBM Verification Architecture
Micron · Richardson, United States, North America
I
Post-silicon Validation and Debug Engineer
Intel · 3 Locations
M
Critical Environment Electrical Engineer
Microsoft · Phoenix, AZ
MT
ASIC Design Verification Engineer
Micron Technology · Minneapolis, MN