Senior Design Quality Engineer - Interventional Oncology

Your responsibilities will include: Responsible for design control and risk management of next-generation medical devices Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) Self-motivated with a passion for solving problems and a bias for action 5+ years of experience in design assurance, new product development or related medical device / regulated industry experience Strong communication skills (verbal & written) Demonstrated use of Quality tools/methodologies Ability to effectively work and collaborate in a mixed onsite + remote environment Demonstrated experience creating detailed technical documents Experience working with medical devices industry ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Experienced problem solver, capable of facilitating the problem-solving process Experience with technology acquisition & integration Experience with design changes, risk management, and corrective action