Design Quality engineer

Katalyst CRO; Cambridge (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

Katalyst CRO, located in Cambridge, Massachusetts, is seeking a qualified candidate to oversee compliance with design controls and risk management throughout the product lifecycle for medical devices. The ideal candidate will have a strong preference for experience in ultrasound and imaging systems.

The position requires understanding of quality standards like ISO 13485 and ISO 14971, and experience with risk analysis, requirement management, and V&V activities.

Responsibilities

• Ensure compliance with design controls in the product lifecycle.
• Perform risk management and verification/validation activities.

Skills

Design controls & product lifecycle

Systems engineering

DFMEA / risk analysis

Requirement management tools (DOORS, Jama, etc.)

V&V execution and review

Regulatory & Standards Knowledge

Education

ISO 13485

ISO 14971

Tools

IEC 60601

IEC 62304

IEC 62366

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