Manager, Product Transfer Project - CR

Lead and own the end-to-end transfer of new and existing medical device products across Terumo Neuro sites, including transfers from R&D to manufacturing and between manufacturing facilities. Accountable for the planning, execution, and successful delivery of transfer programs, ensuring compliance with design transfer requirements, regulatory standards (FDA 21 CFR 820, ISO 13485), and internal Quality Management System procedures. Establish and drive transfer governance, including development of transfer agreements, project plans, resource allocation, and risk management to ensure execution aligned with defined scope, timelines, and business objectives. Ensure readiness and completion of all validation and qualification activities (IQ/OQ/PQ), manufacturing documentation, and training required to support a successful production ramp-up. Lead cross-functional and cross-site teams (Engineering, Quality, Supply Chain, Production, and Regulatory) to resolve risks, remove roadblocks, and ens...