Supplier Engineer - Electronics (Onsite - Acton, MA)
Core
Manage supplier-related engineering activities for electronic components used in medical devices, including new product introductions, process validations, and quality investigations.
Role type
Supplier Engineer (Electronics)
Builds
Electronic components for medical devices (insulin pumps, glucose monitors)
Domain
Medical Devices / Electronics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier engineering, manufacturing engineering, quality engineering, project execution, supplier interface, engineering qualification, root cause analysis (8D, 5 Whys, Fishbone), statistical analysis (Gage R&R, SPC), process validation (IQ/OQ/PQ), regulatory compliance (FDA 21 CFR Part 820, ISO 13485, CAPA, GMP), PFMEA/DFMEA, CTQ concepts, Lean/Six Sigma
Preferred skills
PCBA and battery manufacturing processes, design for manufacturability (DFM), NPI projects, product transfers, cost savings, material changes
Technologies
8D, 5 Whys, Fishbone, Gage R&R, SPC, IQ/OQ/PQ, FDA 21 CFR Part 820, ISO 13485, CAPA, GMP, PFMEA, DFMEA, CTQ, Lean, Six Sigma
Responsibilities
Serve as day-to-day technical liaison between internal teams and suppliers; own execution of defined workstreams within supplier engineering projects; plan and execute engineering qualification activities; track project timelines, risks, and deliverables; support and lead portions of technical investigations related to supplier or product issues; respond to operational escalations and independently resolve routine to moderately complex issues; build and maintain effective working relationships with assigned suppliers; ensure compliance with medical device standards and internal quality systems; contribute to cost reduction, material changes, and product transfer activities; apply structured problem-solving tools to identify root cause and implement corrective actions; develop and review process flows and support process validation activities; perform and interpret statistical analyses; support supplier selection and capability assessments for new or existing components
Seniority
Mid-level, hands-on IC
