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

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.