The individual also serves as a key member of product development teams to perform activities related to design, development, manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. As a lead Quality Engineer on projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for clinical, pilot production and scale-up builds.