Product & Process Development Lead the development and implementation of manufacturing processes for new medical devices or components. Own Design for Manufacturability (DFM) and manage design transfer from R&D to production. Develop and optimize tooling, fixtures, automation strategies, and production workflows. Support Design Verification & Validation (DV&V) activities, including test method development. Conduct cost analysis for manufacturing including capital investments and make/buy decisions. Technical Leadership Serve as the technical subject matter expert (SME) on cross-functional project teams. Collaborate with R&D, Quality, Regulatory, and Operations to ensure product performance and manufacturability. Engage with customers to communicate process capabilities, validation strategies, and DFM recommendations. Lead root cause investigations, corrective actions (CAPAs), and implement design or process improvements. Validation & Compliance Develop and execute IQ/OQ/PQ protocols for equipment and process validation. Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable global regulations. Maintain documentation and traceability in alignment with design controls and quality systems.