Supplier Development Engineer

Capstan Medical, Inc. • Santa Cruz, CA

8d

About The Position

The Supplier Development Engineer (SDE) is responsible for developing, qualifying, monitoring, and improving supplier performance to ensure the consistent delivery of high-quality materials, components, and services. This role serves as a key liaison between suppliers and internal teams to drive quality, delivery, cost, and process improvements while ensuring compliance with applicable regulatory and quality management system requirements, including ISO 13485 and customer-specific requirements. The SDE will lead supplier qualification activities, Process Validation efforts, Production Part Approval Process (PPAP) submissions, supplier audits, corrective actions, and continuous improvement initiatives to support both new product development and ongoing production.

Requirements

• Bachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or related technical discipline.
• 5+ years of experience in Supplier Quality Engineering, Supplier Development, Manufacturing Engineering, Quality Engineering, or related field.
• Experience working within regulated manufacturing environments.
• Demonstrated experience with PPAP, APQP, PFMEA, Control Plans, and MSA.
• Experience conducting supplier audits and managing supplier corrective actions.
• Experience working with ISO 13485 quality management systems.
• Strong understanding of manufacturing processes including machining, molding, assembly, electronics, metals, plastics, or medical device manufacturing.
• Working knowledge of: PPAP, APQP, PFMEA, SPC, MSA, Control Plans, GD&T, Root Cause Analysis, CAPA Systems.
• Proficiency with quality tools and statistical analysis methods.
• Ability to interpret engineering drawings, specifications, and technical standards.
• Experience using ERP, PLM, and quality management systems.

Nice To Haves

• ASQ Certified Supplier Quality Engineer (CSQE), Certified Quality Engineer (CQE), or equivalent certification.
• Lead Auditor certification for ISO 13485 or ISO 9001.
• Six Sigma Green Belt or Black Belt certification.
• Experience supporting FDA-regulated medical device manufacturing environments.

Responsibilities

• Lead supplier selection, qualification, onboarding, and performance management activities.
• Conduct supplier audits and assessments to evaluate manufacturing capabilities, process controls, and quality management systems.
• Develop supplier improvement plans and monitor progress against established metrics.
• Establish and maintain supplier scorecards for quality, delivery, responsiveness, and cost performance.
• Support supplier risk assessments and mitigation activities.
• Lead and review Production Part Approval Process (PPAP) submissions for new and existing suppliers.
• Review and approve key PPAP documentation including: Process Flow Diagrams, PFMEA (Process Failure Mode and Effects Analysis), Control Plans, Measurement System Analysis (MSA), Capability Studies (Cp/Cpk), First Article Inspection Reports (FAIR), Dimensional Results, Material Certifications.
• Ensure process validations and manufacturing controls are implemented and maintained by suppliers.
• Collaborate with suppliers to resolve PPAP deficiencies and qualification issues.
• Ensure supplier compliance with ISO 13485 requirements and applicable regulatory standards.
• Support supplier quality activities associated with medical device manufacturing and applicable regulatory requirements.
• Participate in internal and external audits as subject matter expert for supplier quality processes.
• Ensure supplier documentation, records, and quality systems meet company and regulatory expectations.
• Support change control activities including supplier process changes, material changes, and manufacturing transfers.
• Lead root cause investigations using methodologies such as: 8D, 5 Why, Fishbone Analysis, Fault Tree Analysis.
• Drive supplier corrective and preventive action (CAPA) effectiveness.
• Verify implementation and sustainability of corrective actions.
• Escalate recurring supplier quality issues as appropriate.
• Identify and implement supplier process improvements that enhance quality, reliability, capacity, and cost.
• Utilize Lean Manufacturing and Six Sigma tools to drive continuous improvement initiatives.
• Collaborate with Engineering, Operations, Procurement, and Quality teams to reduce risk and improve supplier performance.
• Support cost reduction and value engineering initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior