Design Assurance Engineer II - (Minneapolis, MN)

Position summary The DA Engineer will lead design assurance initiatives in New Product Introduction programs (NPI), sustaining activities of marketed products (VIP & Supply Continuity projects), and support key quality initiatives for Quality Systems Execution and Continuous Improvement. Duties and Responsibilities Ensure Smiths Medical new product introductions and product design change activities are in compliance with all applicable laws, FDA/EU regulatory qualifications, industry standards, and Smiths Medical Policies and Procedures. Support deployment and continuous improvement of internal development procedures including Design Control, Risk Management, Post Market Surveillance, and Statistical Techniques to drive robust designs and support the life cycle maintenance of product risk and design documentation. Support rigorous planning activities in relation to design control (DDP) and risk management deliverables.