What are the responsibilities and job description for the Design Quality Engineer position at Yochana?
Role: Design Quality Engineer
Location: Bothell, WA, Cambridge, MA, Plymouth, MN and Reedsville, PA (Onsite)
Duration: Full Time
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