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 closely with Research and Development, Regulatory, Medical Affairs and Quality Operations teams to ensure timely identification, documentation, and resolution of design-related quality issues
Work on projects of moderate scope and complexity, identify opportunities for continuous improvement, and lead activities to implement improvements with general guidance
Support all company initiatives identified by leadership and be accountable for on-time completion of training, tasks, projects, and quality plans

Bachelor’s degree in engineering or related field preferred
2+ years of experience preferred
Knowledge of medical device design and development, risk management processes, statistical analysis tools, root cause analysis, and continuous improvement
Understanding of industry standards, guidelines, and regulations (i.e. AAMI & ANSI standards, GMP, 21CFR820, ISO14971, IEC62366, ISO 13485)
Strong attention to details, organizational, problem-solving, and technical writing skills
Confident communicator and ability to collaborate cross-functionally
Travel Expectations: 10%

Senior Design Quality Engineer – Medical Devices

Key skills