Drive the implementation of holistic Systems Engineering principles within the Design Controls process, with a focus on system architecture and integration, Design Inputs, traceability, risk management, change management, and DHF architecture. * Lead system and use-related risk management activities, including risk planning and reporting, system risk assessments, and design and process FMEAs. * Collaborate with cross-functional teams to plan and coordinate testing activities, including sample and laboratory resource planning, and drive improvements to processes, methods, and ways of working. * Strong Expertise in Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, and change management * Expertise in DHF management and creating various Des
mehr