Leadership of Line Transfers (Site-to-Site / Line Transfers) Lead the planning, execution, and completion of manufacturing line transfers between plants (e.g., US → Mexicali), ensuring operational continuity and regulatory compliance. Define and manage the Transfer Plan: scope, timeline, risks, resources, and success metrics. Ensure the complete transfer of: Processes (manufacturing, inspection, testing) Equipment and tooling Documentation (DHF/DHR, BOM, routers, work instructions) Coordinate Run-at-Rate activities, pilot builds, and ramp-up until target production capacity is reached. Manage risks through FMEA and mitigation plans during the transfer. Ensure compliance with quality standards during “dual production” or transitional phases. Process Validation Management (IQ/OQ/PQ) Lead the strategy and execution of process and equipment validations in accordance with ISO 13485, FDA 21 CFR Part 820, and corporate guidelines. NPI (New Product Introduction) Support Lead the industrialization of new products from the design phase through commercial production. Collaborate with R&D teams to define and execute: Engineering builds, pilot builds, and process validations. Develop manufacturing capabilities: production lines, fixtures and tooling, and inspection methods. Ensure manufacturing readiness for product launch and ramp-up. Manage engineering change orders (ECOs) during NPI phases. Regulatory Compliance and Quality System Ensure that all activities comply with: FDA 21 CFR Part 820 (Design Controls & Process Validation) ISO 13485 Cross-Functional Team Management Lead cross-functional teams including: Manufacturing Engineering, Quality Engineering, R&D, Supply Chain, Operations. Serve as the central point of communication for transfers and NPI projects. Manage internal and external stakeholders (including suppliers). Develop technical talent and strengthen team capabilities. Required Candidate must be of high character and energy with regard for detail. Strong NPI Processes and Projects Strong Transfers experience is mandatory Demonstrated Mechanical and/or Process Engineering ability. Demonstrated ability in failure analysis and continuous improvement. BS degree in Mechanical Engineering or equivalent. Minimum 3 years manufacturing engineering supervision experience with Mid/high volume complex manufacturing processes. Preferred MS degree in an Engineering discipline. 7 to 8 years of experience as design or manufacturing engineer supporting product with significant mechanical/process content. Prior experience with various mechanical and or electronics applications and technologies, including reliability and performance assessment. Prior experience working in FDA 21 CFR820/ISO 13485 medical device manufacturing environment. Demonstrate ability to design/execute experiments. Prior responsibility for process or product validation/verification. Experience with ASME Y14.5 Geometric Dimensioning and Tolerance. Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques. #J-18808-Ljbffr