Sr Supplier Engineer
Core
Ensure high quality and stable delivery of purchased production components from suppliers for medical device manufacturing.
Role type
Senior Supplier Engineer (Manufacturing/Quality)
Builds
Production parts and components for surgical robots
Domain
Medical Devices / Surgical Robotics
Required skills
Supplier quality management, Part Qualification, pFMEA, Root Cause Analysis (8D, 5 Why), Process Capability Analysis, DFM, Supplier Selection & Evaluation, Change Management (ECO/SCR), Manufacturing Process Selection, QMS Auditing, 21 CFR part 820, ISO 13485, GDP
Preferred skills
Medical device industry experience, Low-volume high-mix production experience, Plastic Injection Molding/Die casting knowledge, SAP/ERP proficiency, International travel
Technologies
SAP, ERP, Windows, MS Office Suite
Responsibilities
Lead Part Qualification requirements definition and testing; Complete Production Part Qualification deliverables (pFMEA, FAI, Process Capability); Drive corrective actions using Root Cause tools; Lead manufacturing process selection and DFM; Manage supplier change requests and specifications; Evaluate and select new suppliers; Foster supplier relationships and audit compliance.
Seniority
Senior, hands-on IC