Senior Design Assurance Engineer

Your responsibilities will include: Work within a cross-functional team to identify and implement effective controls and support product development through commercialization. Responsible for design control, risk management & Usability of next-generation capital equipment, Ultrasound Imaging 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). Bachelor's Degree in Engineering (Electrical Engineering, Systems Engineering, Biomedical) 5+ years of relevant work experience Knowledge of Ultrasound imaging devices & IEC 60601-2-37 Knowledge of ISO 13485, ISO 14971, IEC 62366-1 Experience with design controls, design inputs and outputs, and risk mitigation activities Experience with systems and electrical/software design and test experience with IEC 60601-1 and collateral standards Excellent analytical and communication skills (written and oral) Excellent organization and time management skills Interest in biomedical or health-related industry 2+ years of experience in a Design Assurance role 5+ years of experience in the medical device industry