Design Quality engineer

Katalyst CRO; Cambridge (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in Cambridge, MA seeks a Regulatory/Quality Systems Engineer to ensure design controls, risk management, and V&V alignment across the product lifecycle for medical devices.

Candidates should have strong systems thinking, experience with ISO 13485 and ISO 14971, and familiarity with IEC 60601/62304. This role emphasizes early design gap identification and risk-based decision making.

Qualifications

• Experience with design controls and product lifecycle processes in medical devices.
• Strong systems engineering background.
• Familiarity with risk management and V&V activities.

Responsibilities

• Ensure compliance to design controls, risk management, and verification/validation across the product lifecycle.
• Identify design gaps and drive risk-based decisions.
• Coordinate with regulatory teams to align with standards.

Skills

Design controls

Systems engineering

Education

ISO 13485

ISO 14971

Tools

DOORS

Jama

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.

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)

Strong systems thinking Ability to:

• Identify design gaps early
• Drive risk-based decisions