Supplier Development Engineer II

• Develop, qualify, and continuously improve supplier performance within a highly regulated medical device manufacturing environment
• Partner with suppliers and cross‑functional teams to ensure components and materials consistently meet technical, quality, delivery, and regulatory requirements
• Drive supplier capability improvement, risk mitigation, supplier qualification, and supply continuity initiatives that support product quality and business objectives
• Conduct supplier audits and assessments and support supplier onboarding, qualification, and design transfer activities, including supplier readiness, tooling transfers, and first article inspections (FAIs)
• Monitor supplier performance, identify risks and trends related to process quality, delivery, capacity, and business continuity, and implement appropriate improvement and mitigation plans in collaboration with Quality Assurance and Materials teams
• Evaluate supplier change notifications, engineering changes, and specification changes to ensure appropriate qualification, change control, and regulatory compliance

• 3–7 years of experience in supplier quality, supplier development, manufacturing engineering, or a closely related field
• Bachelor’s degree in Manufacturing, Mechanical, Industrial, Biomedical Engineering, or a closely related discipline required
• Direct experience working with external suppliers on quality and technical matters; medical device, electronics, or other regulated manufacturing experience preferred
• Working knowledge of FDA Quality Management System Regulation (QMSR) (21 CFR Part 820) and/or ISO 13485 required; supplier qualification or audit application preferred
• Proficient in ECO/change management systems, document control, data analysis, and Microsoft Office Suite; statistical analysis tools preferred
• Able to read and interpret engineering drawings and GD&T required
• Familiarity with ERP or supplier management systems (e.g., D365, SAP) preferred
• Experience with supplier auditing, FAI, incoming inspection, process validation (IQ/OQ/PQ), or supplier quality improvement initiatives preferred

Demonstrates expertise in supplier quality management, including supplier qualification, auditing, and regulatory compliance within the medical device manufacturing sector. Proficient in risk mitigation, process validation, and collaboration with cross‑functional teams to enhance supplier performance and ensure product quality.