Lead Manufacturing Process Engineer
Core
Lead manufacturing process development, optimization, validation, and continuous improvement for medical devices involving vacuum furnaces, brazing, machining, drilling, and milling.
Role type
Lead Manufacturing Process Engineer
Builds
Robust and repeatable manufacturing processes for new and existing medical device products
Domain
Medical technology / Manufacturing engineering
Required skills
Vacuum furnace operations, brazing processes, process validation, root cause analysis, equipment qualification, Lean manufacturing, project management, cost roll-up analysis, manufacturing layout design, corrective and preventive actions
Preferred skills
Healthcare industry experience, ISO 13485 certification knowledge, team management
Technologies
Oracle, vacuum systems, machining tools, drilling equipment, milling equipment
Responsibilities
Lead manufacturing process design, development, setup, industrialization, and validation; Lead product and process change management including SOPs and PFMEAs; Provide technical leadership for vacuum furnace, brazing, machining, drilling, and milling processes; Lead equipment qualification, verification, validation, and manufacturing readiness; Analyze quality trends and drive corrective actions; Maintain product BOMs and cost data in Oracle; Drive cycle-time reduction and waste elimination; Lead NPI, product transfer, and VCP projects; Drive Lean manufacturing and error-proofing initiatives; Lead manufacturing layout and process-flow optimization; Support specification and management of manufacturing tools and capital assets; Develop safe manufacturing processes with risk-control measures; Collaborate with cross-functional teams to improve operational performance.