Staff Supplier Industrialization Engineer
Core
Senior Supplier Industrialization Engineer acting as the technical bridge between R&D and global contract manufacturing (CM) networks for medical devices.
Role type
Senior individual contributor Supplier Industrialization Engineer
Builds
Global supply chain for point-of-care EEG platforms and precision medical devices
Domain
Medical technology / Electromechanical manufacturing / Regulatory compliance (FDA/ISO)
Deliverable
Production ML models | product features | infrastructure
Required skills
Global vendor management, NPI industrialization, should-cost modeling, capacity planning, validation lifecycle management (IQ/OQ/PQ), PPAP leadership, sub-tier traceability, DFM/DFA/DFS feedback, root-cause analysis (8D/5-Why), automation qualification, tooling control
Preferred skills
M.S. in Engineering, experience with highly regulated electromechanical systems, experience with overseas design transfers
Technologies
None explicitly listed as tools/frameworks (focus on processes and standards like 21 CFR 820, ISO 13485, IPC-A-610)
Responsibilities
Evaluate and approve factory-level engineering plans across US, China, and Vietnam; Lead technical evaluation of vendor RFPs and formal qualification of new CMs; Manage engineering change oversight (ECOs/DCOs) to ensure supply chain continuity; Develop capacity models and optimize transition to high-volume production; Lead validation lifecycle and Supplier PPAP framework; Conduct technical audits and root-cause analysis at overseas sites; Represent Supply Chain in R&D reviews for DFX feedback
Seniority
Senior, hands-on IC
