Design Quality Engineer - Medical Devices (Risk & V&V)

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

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.