Director, Design Quality Assurance, NPI (Hybrid)

Job description

Position Overview: The Director, New Product Introduction (NPI), Design Quality Assurance, is responsible for leading Design Quality Assurance (DQA) strategy and execution across all new product development programs, ensuring the compliant, efficient, and high‑quality introduction of medical devices into the market. This role oversees design quality activities spanning systems, software, hardware, digital applications, cloud components, and connected device ecosystems. The Director provides strategic leadership to ensure that NPI programs meet global regulatory requirements, internal quality expectations, and product performance targets across Class I, II, and III medical devices. This includes establishing robust design control practices, driving cross‑functional integration quality, ensuring risk‑based decision‑making, and overseeing Design History File (DHF) completion and compliance. This position requires a high level of technical depth across software, systems engineering, digital applications, and cybersecurity, combined with strong leadership capabilities to influence design quality across the organization. The Director partners closely with R&D, Systems Engineering, Softwa...