Senior Design Quality Engineer

BS in Mechanical / Biomedical Engineering or related discipline or equivalent combination of education and experience to perform at this level 5+ years' experience in design quality or related quality field; or equivalent combination of education and experience to perform at this level 2+ years' experience with MedTech device design and development Demonstrated use of Quality tools and methodologies with an emphasis on Design Controls and Risk Management Experience leading Design Quality projects Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability) Ability to travel up to 10% Demonstrated experience developing and launching catheter based medical devices Strong technical knowledge, problem-solving capabilities, collaborative mindset, and effective communication skills Comfortable working ‘in the gray;' known for innovative, out of the box thinking to identify novel approaches to meeting requirements Experience with devices used in the treatment of carotid artery disease 1-2 years' supervisory experience of technical personnel Working knowledge of human factors / usability engineering Six Sigma Black Belt