Manager, Supplier Engineering

Job Description

Primary Function of Position

Manage and lead a team of Supplier Engineers responsible for ensuring supplier manufacturing processes are capable, stable, compliant, and scalable across the product lifecycle. This role plays a critical part in protecting the validated state of medical devices, enabling safe and timely product launches, and driving sustained improvements in supplier quality, capacity, and risk reduction.

The Supplier Engineering Manager leads complex, cross‑functional problem solving at the intersection of supplier manufacturing processes, design constraints, quality systems, and business priorities. Success in this role requires strong engineering judgment, the ability to operate effectively in ambiguous environments, and the authority to influence decisions that directly impact patient safety, product performance, and business outcomes.

Essential Job Duties

Team Leadership and Development.

• Lead and develop a team of Supplier Engineers accountable for driving measurable quality and performance improvements at suppliers, ensuring deep understanding of process inputs, outputs, and sources of variation through hands‑on engagement, data‑driven analysis, and on‑site problem solving.
• Coach, train, and performance‑manage the team by setting clear expectations, building technical depth, and holding engineers accountable for results through regular feedback, development plans, and outcome‑based goals.
• Develop the team’s engineering judgment by coaching decision‑making under ambiguity and effective tradeoff evaluation across quality, cost, risk, and schedule.
• Partner closely with Design, Quality, Supply Chain, Manufacturing, and supplier leadership to align on technical requirements, risk, and priorities, influencing decisions to ensure supplier processes meet quality, cost, delivery, and compliance objectives.

Component and Process Qualification

• Promote Design for Manufacturability (DFM) by engaging suppliers and Engineering early in the development cycle to provide actionable feedback on manufacturability improvements prior to production.
• Own and govern supplier component qualification, holding suppliers and internal teams accountable for robust execution of FAIR, test method development and validation, PFMEA / spFMEA, capability studies (Cp/Cpk, GR&R), and complete, compliant documentation to support safe launch and sustained production.

Component Quality

• Lead supplier non‑conformance management by driving rigorous root cause analysis (e.g., 8D, 5‑Why, Fishbone) and ensuring timely, effective corrective and preventive actions to prevent recurrence.
• Drive sustained reduction of supplier defects using data‑driven insights, trend analysis, and supplier leadership engagement to improve process capability, quality performance, and regulatory compliance.
• Lead or support CAPA and SCAR activities arising from recurring supplier qualification issues or field complaints attributable to component performance

Process Maturity through Supplier Capacity and Risk Management.

• Own supplier manufacturing process maturity across the product lifecycle, ensuring processes remain capable, stable, and scalable beyond initial qualification.
• Lead proactive supplier and component risk identification and mitigation, using data and engineering judgment to prioritize effort on high‑severity and high‑impact area
• Partner with suppliers and Supply Chain to assess and improve manufacturing capacity, scalability, and tooling readiness to support volume ramps without compromising quality or validated state.
• Own and govern Supplier Change Requests (SCRs) ensuring changes are well planned, risk‑assessed, executed on time with authority to recommend approval, rejection, prioritization, and escalation of supplier actions based on risk, data, and business impact.
• Ensure supplier changes do not compromise the validated state by driving appropriate impact assessments, validation strategy alignment, and cross‑functional approvals to maintain product quality, compliance, and supply continuity.