KH
Design Quality engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
4 months ago
- Risk Management
- IEC
4 months ago
Not enough detail in this posting to match
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
Design Quality engineer · Katalyst Healthcares & Life Sciences