The Senior Manager, Device Development is accountable for the technical development of Xeris’ device and combination product programs to ensure commercialization strategy and objectives are met. This role identifies and leads development projects for device and combination product delivery systems, according to established standards for Design Controls and product development processes. This includes providing leadership to a cross-functional team, encompassing all aspects of device development: design input, design output, specification development, test method development, design verification/ validation, process validation, design transfer, and risk management. The Senior Manager leads the coordination and collaboration with contract development and manufacturing organizations (CDMOs), by serving as the key liaison between internal departments and these key external stakeholders. This role is also responsible for compiling and maintaining the Device History File (DHF) and Device Master Record (DMR) and makes significant contributions to associated regulatory submissions .