Head of Operations and Manufacturing - Medical Device (Hybrid or Remote)

Head of Operations and Manufacturing role leading end-to-end operational infrastructure to manufacture FDA-cleared medical devices at scale. Responsible for selecting contract manufacturers with Class II device experience, overseeing design transfer and manufacturing transfer (DFM, DMR, DHR), production planning and capacity management, and driving continuous improvement for yield, quality, and cost while ensuring FDA and ISO compliance. Manages supply chain end-to-end, including supplier qualification, inventory planning, and risk mitigation. Maintains ISO 13485 QMS and supports 510(k) submission activities related to manufacturing, including process validation documentation and device history records. Defines incoming inspection, in-process controls, and final product testing; oversees certifications (FDA registration, UDI) and post-market surveillance. Leads direct-to-patient fulfillment strategy with 3PL, and builds the operations team through 510(k) clearance to launch. Strong collaboration with engineering, regulatory, finance, and commercial teams.