Design Quality Engineer III
The Design Quality Engineer will play a central role in ensuring the safety, reliability, and regulatory compliance of new and existing medical device products. This position focuses heavily on ISO-compliant risk management throughout the product lifecycle, partnering closely with R&D, Regulatory Affairs, Manufacturing, and Quality Systems teams. The ideal candidate brings strong analytical skills, deep understanding of design controls, and hands-on experience guiding engineering teams through risk-based decision-making.
Responsibilities

+ Lead the development, execution, and maintenance of risk management files in accordance with ISO standards, including hazard analysis, FMEA, fault tree analysis, and benefit–risk assessments.

+ Support design control activities per 21 CFR 820.30, ensuring risk management is fully integrated into design planning, verification, validation, and design transfer.

+ Collaborate with cross-functio...