Director, Industrial Launch Leader
Core
Lead end-to-end New Product Introduction (NPI) from design freeze through manufacturing transfer, qualification, and ramp-up for medical device products.
Role type
Senior Director, Industrial Launch & Program Management
Builds
Medical device products (dialysis platforms) ready for commercial launch
Domain
Medical Devices / Biomedical Engineering
Required skills
Program management, cross-functional team leadership, design transfer, manufacturing process validation, supply chain capacity planning, risk mitigation, supplier qualification, regulatory clearance management, demand planning
Preferred skills
Advanced degree in engineering, experience with multicomponent therapy systems, global team leadership
Technologies
IQ/OQ/PQ validation, OEE, PSW, CPK analysis
Responsibilities
Lead Design Verification & Validation and Design Transfer preparation; Drive alignment between engineering, manufacturing, and supply chain to minimize industrialization risk; Ensure rigorous production process validations (IQ/OQ/PQ) and scale for capacity; Evaluate supplier selection and technical capability; Validate supplier readiness through OEE trial runs; Drive end-to-end demand, capacity, and inventory planning across the value chain.
Seniority
Director, 15+ years experience
