Manager, Supplier Engineering

IntuitiveSunnyvale, CA

About The Position

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.

Requirements

  • Proven ability to lead and scale engineering teams to solve increasingly complex technical and manufacturing process problems by applying data‑driven analysis and strong engineering judgment.
  • Demonstrated experience hiring, developing, mentoring, and retaining high‑performing engineering talent.
  • Comfortable operating in ambiguous environments, balancing competing priorities, incomplete data, and cross‑functional tradeoffs to drive timely, high‑quality decisions.
  • Demonstrated ability to apply broad supplier manufacturing process knowledge to assess tradeoffs and make risk‑based decisions affecting product quality, cost, capacity, scalability, and supplier performance.
  • Demonstrated ability to read and interpret engineering drawings and GD&T, with sufficient depth to evaluate manufacturability, inspection strategy, and risk, and to guide technical decision‑making
  • Proficiency in PFMEA / spFMEA, process validation, root cause investigation, inspection, and test methodologies.
  • Experience with document management systems and ERP platforms; Agile and SAP preferred.
  • Excellent written and verbal communication skills, including the ability to present effectively to executive‑level management.
  • Demonstrated project management skills.
  • Ability to travel domestically and internationally to supplier sites as needed.
  • BA or BS degree in engineering
  • 12 or more years related experience in Manufacturing, Operations, Supplier Engineering, or related field with significant medical or medical device experience preferred
  • Minimum 5 years of experience leading engineering teams, or leadership of equivalent areas.

Nice To Haves

  • Knowledge of 21 CFR part 820 and ISO 13485 preferred
  • Financial knowledge and ability to calculate Net Present Value (NPV)
  • Ability to create dashboards (Smartsheets or Confluence) to track and management projects and deliverables for accountability and transparency.

Responsibilities

  • 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.
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