Design Quality Engineer II

Your responsibilities will include: Develops understanding of Design Controls, Risk Management and Usability for Medical Devices. Supports departmental, functional, and divisional design quality goals and priorities. Executes methodologies to effectively meet individual and team objectives. Bachelor of Science in Mechanical / Biomedical Engineering or related discipline in the sciences. Minimum of 2+ years experience in Design Quality Assurance, related experience in quality engineering or NPD design within a regulated industry Understanding of Quality tools and methodologies with an emphasis on Design Controls, Root Cause Analysis and Risk Management. Strong communication skills (verbal & written) Ability to work independently and as part of a team. Comfortable with complaint data reviews and interpretation Ability to travel up to 10%. Experience with pharmaceutical or combination medical device development Working knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820, 210, 211 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability). Experience with medical device development for single use device Experience with Electronic Medical Equipment.