Manager – Supply Chain Engineering

Manager – Supply Chain Engineering

Requirements

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related field.
• 7+ years of experience in supplier qualification, manufacturing engineering, or process engineering in the medical device industry.
• 2+ years of experience in leading and managing teams in supply chain or engineering roles.
• Proven track record of managing overseas suppliers and supporting high-volume production.
• Strong knowledge of FDA (21 CFR Part 820), ISO 13485, and ISO 9001 requirements for medical devices.
• Experience in qualifying suppliers for molding, automation, and process improvements.
• Experience supporting New Product Introduction (NPI) and scaling supplier processes for mass production.
• Strong leadership and people management skills, with the ability to mentor and develop high-performing teams.
• Proficiency in quality tools such as FMEA, SPC, 8D, and Root Cause Analysis.
• In-depth understanding of automation systems and process improvement methodologies.
• Excellent problem-solving, analytical, and project management skills.
• Effective communication and relationship management skills, particularly with overseas suppliers.

Responsibilities

• Oversee the supplier qualification process, ensuring new and existing suppliers meet engineering, quality, and production standards.
• Conduct and lead on-site audits at overseas supplier locations to evaluate manufacturing capabilities, compliance with FDA (21 CFR Part 820) and ISO 13485 standards, and overall quality systems.
• Develop and implement robust qualification strategies, including process capability studies, First Article Inspections (FAI), and Production Part Approval Process (PPAP).
• Lead technical reviews to assess supplier engineering capabilities, including tooling design, automation systems, and high-volume manufacturing readiness.
• Provide guidance to suppliers in resolving quality and process issues, emphasizing continuous improvement and process optimization.
• Identify and drive opportunities for automation and process enhancements at supplier facilities.
• Support the successful introduction of new products by ensuring suppliers are prepared for production at required quality and capacity levels.
• Work closely with R&D and Product Design teams to ensure supplier capabilities align with new product requirements.
• Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) discussions to optimize supplier processes for NPI.
• Oversee supplier validation and qualification activities for new product launches, ensuring seamless transitions from development to production.
• Establish scalable supplier processes to support volume ramp-up and long-term manufacturing success.
• Partner with Quality, Product Design, R&D, and Operations teams to align supplier capabilities with product specifications and regulatory requirements.
• Lead cross-functional Design for Manufacturability (DFM) reviews to ensure supplier processes can meet product design requirements at scale.
• Act as a key liaison between suppliers and internal teams to resolve engineering and production challenges.
• Drive supplier process improvement initiatives focused on automation, defect reduction, and efficiency gains.
• Establish and monitor Key Performance Indicators (KPIs) such as defect rates, on-time delivery, and yield rates, implementing corrective actions as needed.
• Ensure suppliers comply with GMP, FDA, ISO 13485, and ISO 9001 requirements through strong auditing and qualification processes.
• Conduct risk assessments and implement mitigation strategies to address potential supply chain disruptions.
• Lead efforts to qualify second-source suppliers to reduce risks and improve supply chain resilience.
• Collaborate with Procurement to drive cost reduction initiatives through process optimization and supplier negotiations.
• Maintain comprehensive supplier qualification documentation, audit reports, and corrective action plans.
• Provide regular reports on supplier performance, risks, and improvement initiatives to senior management.
• Ensure accurate and timely documentation of non-conformance reports (NCRs), corrective actions (CAPA), and other compliance-related activities.
• Lead, mentor, and develop a team of supplier engineers, fostering a culture of technical excellence and continuous improvement.
• Establish team goals, provide performance feedback, and support career development of team members.
• Coordinate cross-functional initiatives to enhance supplier qualification and process optimization.

Preferred Qualifications

No preferred qualifications provided.