Manufacturing Line Readiness & Scalability: Lead end-to-end production line setup, including procurement, installation, and validation of fixtures, tooling, and equipment under copy-exact principles to ensure global replication. Maintain “golden unit” standards with rigorous documentation (BOMs, Work Instructions) and comply with change control. Conduct manufacturing readiness reviews, optimize capacity models, and collaborate with Supplier Development, Quality, and cross-functional teams (IT, Facilities, Supply Chain, Warehouse) to align infrastructure (cleanrooms, material flow, MRP setup) for rapid scale-up.