Sr Supplier Manufacturing Engineer, Machining
Core
Ensure suppliers meet quality, service, delivery, and cost requirements for medical device manufacturing; drive continuous improvement in supplier processes and select optimal suppliers for new product designs.
Role type
Senior Supplier Manufacturing Engineer (Machining/Molding)
Builds
Medical device components via metal injection molding (MIM), plastic injection molding (PIM), and machining
Domain
Medical device manufacturing / Advanced manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing process validation and supplier management)
Required skills
Metal injection molding (MIM), plastic injection molding (PIM), machining, supplier selection and development, process validation (IQ/OQ/PQ), root cause analysis, corrective and preventive actions (CAPA), project management, Lean/6 Sigma/SPC, statistical analysis, GD&T interpretation, 21 CFR part 820 and ISO 13485 knowledge
Preferred skills
Scientific Injection Molding (SIM) principles, silicone molding (LSR/compression), CAD (SolidWorks), Minitab, high-volume medical device company experience, new product development
Technologies
SAP, Agile, Minitab, SolidWorks, Windows, Excel, Project, Access
Responsibilities
Execute supplier qualification deliverables including pFMEA, Process Validations, Inspection Reports, Gage R&R, and Process Capability Analysis; drive cost reductions, capacity improvements, and supply chain risk mitigation; manage supplier changes including process and facility modifications; lead supplier variances from symptom through root cause analysis to corrective action; collaborate on new product introductions to assess launch readiness and develop ramp plans; influence engineering in supplier selection and preferred supplier development; generate key metrics and drive timely achievement of supplier performance goals.
Seniority
Senior, hands-on IC