Sr Design Quality Engineer – Medical Devices

Job description

Sr Design Quality Engineer – Medical Devices Job Summary: Design Quality Engineering drives quality excellence throughout the design and development life cycle of medical devices. This function ensures robust design control processes including risk management, design planning, design verification, design validation, and preparation for design transfer. Design Quality Engineering collaborates with cross- functional teams contributing to resolution of quality issues, development and adherence to quality policies, procedures, and processes to ensure compliance with regulatory standards, and achievement of long-term quality strategies. Schedule: Hybrid. 3x a week in office. Responsibilities: - Participate in creation, review and approval of medical device design and development files including design planning, design inputs & outputs, design verification & validation, and design transfer plans. - Develop and maintain risk management files throughout the product lifecycle, across a broad set of technologies with clear and thorough identification of hazards, hazardous situations, risk estimation and analysis, and mitigation activities to ensure continued acceptability of products. - Work...