Manager, Supplier Engineering
Core
Lead a team of Supplier Engineers to ensure supplier manufacturing processes are capable, stable, compliant, and scalable across the product lifecycle for medical devices.
Role type
Senior Manager, Supplier Engineering
Builds
Validated medical device manufacturing processes and component qualifications
Domain
Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing process validation)
Required skills
Team leadership and development, Design for Manufacturability (DFM), component qualification (FAIR, PFMEA, Cp/Cpk), root cause analysis (8D, 5-Why), risk management, engineering judgment, GD&T interpretation, project management
Preferred skills
Knowledge of 21 CFR part 820 and ISO 13485, financial analysis (NPV), dashboard creation (Smartsheets, Confluence)
Technologies
SAP, Agile, document management systems
Responsibilities
Lead and develop a team of Supplier Engineers, govern supplier component qualification, lead non-conformance management and CAPA activities, manage supplier change requests (SCRs), assess manufacturing capacity and scalability
Seniority
Senior, hands-on IC with leadership responsibilities