Imaging Systems Quality Engineer (Medical Devices)

Katalyst CRO; Cambridge (MA); On-site; Full time

Job description

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 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