Design Quality Engineer II

Develops understanding of Design Controls, Risk Management and Usability for Medical Devices Support the development of design input and output documents Support the development and implementation of design verification and validation plans Support product risk management, usability, and reliability efforts for new product development and design change projects Supports departmental, functional, and divisional design quality goals and priorities Executes methodologies to effectively meet individual and team objectives BS in Mechanical / Biomedical Engineering or related discipline 2+ years' experience in design quality or related field; or equivalent combination of education and experience to perform at this level Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management 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) Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills Ability to travel up to 10% Experience developing and launching catheter based medical devices Ability to work independently and as part of a team Experience with devices used in the treatment of carotid artery disease Working knowledge of various statistical techniques, such as DoE, CoV, MSA, etc. Understanding of human factors / usability engineering