The Design Quality Engineer is responsible for providing support to new product development teams, including Design Input, Verification Testing, Risk Management and Design Transfer activities.
1. Provide quality engineering and reliability input to all new projects, including establishment of quality and reliability design constraints and design evaluation criteria.2. Plan, coordinate, execute and lead design verification testing against product requirement specifications3. Oversee the Risk Management program, including creating Risk Management Plans, coordinating risk analyses, participating in FMEA’s, and maintaining Risk Management Reports and Files.4. Participate in design reviews to ensure customer and regulatory requirements have been properly translated in to design inputs which are complete, unambiguous and do not conflict.5. Write, review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes.6. Develop understanding of current product to assist with product updates and maintenance releases.7. Assist in the preparation of design documentation to ensure the Design History File is maintained.8. Assist with creating Essential Requirements Checklists and Technical Files for EU submissions.9. Create, implement and teach new quality systems as required.
Minimum Requirements1. BS degree in Engineering discipline or equivalent degree + experience2. Minimum of eight years’ experience in engineering related industry, of which 5 years should be in the medical device industry.3. Direct experience with FDA QSR and ISO 13485 compliance.4. Knowledge of development, validation and manufacture of medical devices.5. Direct experience with electro-mechanical equipment required, including IEC 60601, EMC and UL requirements.