Sr. Supplier Engineer

We are seeking a highly analytical and detail‑oriented Supplier Engineer to ensure suppliers consistently meet requirements for quality, delivery, capacity, cost, and service. This role serves as the primary technical interface between manufacturing teams and suppliers, driving issue resolution, process improvements, and supplier performance to support uninterrupted production.

The Supplier Engineer partners closely with Manufacturing, Quality, Planning, Operations, Engineering, and Procurement teams to qualify supplier processes, support New Product Introduction (NPI), manage supplier changes, and drive continuous improvement initiatives.

• Serve as the primary technical contact for supplier‑related quality, delivery, capacity, and manufacturing issues.
• Lead issue resolution activities, including containment, root cause analysis, and corrective/preventive actions.
• Investigate and resolve supplier‑related non‑conformances, deviations, and first‑article inspection issues.
• Monitor supplier performance metrics and drive improvement initiatives.
• Proactively identify and mitigate supplier risks impacting production.

• Partner with suppliers to improve manufacturing processes, process capability, inspection methods, and process controls.
• Drive continuous improvement using Lean Manufacturing, Six Sigma, SPC, and structured problem‑solving methodologies.
• Lead investigations into recurring defects, process variation, and manufacturing inefficiencies.
• Improve yield, reduce variability, and strengthen manufacturing robustness.
• Execute supplier qualification and validation activities, including:
  • pFMEA
  • IQ/OQ/PQ validations
  • First Article Inspections (FAI)
  • Process capability analysis (Cp/Cpk)
• Support and approve supplier process changes, including equipment, tooling, process transfers, and facility changes.
• Support ECO implementation and supplier readiness for NPI and production ramp‑up activities.
• Identify and mitigate supplier‑related quality, capacity, and continuity risks.
• Drive supplier development and continuous improvement projects.
• Support supplier audits, process reviews, and operational assessments.
• Track supplier performance and provide data‑driven recommendations.

• Collaborate with Manufacturing, Quality, Supply Chain, Procurement, and Engineering teams to achieve production objectives.
• Communicate supplier risks, recovery plans, and project status to stakeholders.
• Build strong supplier relationships and provide technical recommendations with minimal supervision.

• Bachelor's degree in Mechanical, Manufacturing, Biomedical, Electrical Engineering, or a related technical discipline.
• 2–5 years of experience in Supplier Engineering, Supplier Quality, Manufacturing Engineering, Quality Engineering, or a related field.
• Experience supporting manufacturing environments; medical device or regulated industry experience is preferred.
• Experience with manufacturing processes such as machining, injection molding, stamping, extrusion, MIM, or assembly processes.
• Experience supporting New Product Introduction (NPI) is preferred.

• Strong root cause analysis and problem‑solving skills.
• Working knowledge of pFMEA, process validation, SPC, statistical analysis, inspection methodologies, and CAPA systems.
• Familiarity with Lean Manufacturing and Six Sigma principles.
• Proficiency with Microsoft Office applications, especially Excel.
• Experience with ERP and document management systems (SAP, Agile preferred).
• Experience with Minitab or similar statistical tools preferred.
• CAD experience is a plus.

• Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
• Lean Manufacturing and/or Six Sigma certification.
• Experience working with suppliers and contract manufacturers.
• Experience supporting supplier escalation and recovery activities.