Senior Design Assurance Engineer - DQE - AV&I

Support design controls and quality management for the development, transfer, and sustaining of medical devices. Lead quality elements of Design Controls and Design History Files, drive design-engineering quality norms, and integrate risk management and quality system requirements across the product lifecycle through post-market surveillance. Perform CAPA and continuous improvement initiatives, analyze field performance trends, coordinate transfers of quality deliverables to manufacturing teams, and support regulatory affairs and internal/external audits.