Sr. Supplier Engineer
Core
Ensure suppliers meet quality, service, delivery, and cost requirements; drive continuous improvement in manufacturing processes and select suppliers for new products.
Role type
Senior Supplier Engineer (Medical Devices)
Builds
Production-ready medical device components via contract manufacturers
Domain
Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (supplier qualification & process validation)
Required skills
Supplier selection and development, Part Qualification (PPQP), pFMEA, Process Validation (IQ/OQ/PQ), Root Cause Analysis, CAPA management, Cost reduction, Capacity planning, Risk mitigation, DFM input, Project management, Six Sigma, Lean, SPC, Negotiation
Preferred skills
Plastic Injection Molding, Metal Injection Molding, Contract Manufacturing, 21 CFR part 820, ISO 13485, High-volume medical device experience, SAP/Agile systems
Technologies
SAP, Agile, ERP systems
Responsibilities
Complete Part Qualification deliverables including pFMEA and Process Validations; Execute cost reductions and capacity improvements with suppliers; Select processes and suppliers for new parts; Manage supplier changes and new equipment qualification; Drive changes to ISI requirements via engineering change orders; Own supplier variances from root cause analysis to corrective action; Develop supplier ramp readiness plans and product landscapes; Provide DFM feedback to engineering; Review and close customer complaints and manufacturing variances.
Seniority
Senior, hands-on IC