Salary
💰 $119,550 - $179,325 per year
About the role
- Own and lead the supplier engineering strategy for NPI programs, ensuring alignment with product launch timelines and manufacturing scalability
- Oversee supplier validation activities including component qualification, tooling deployment, and process capability assessments
- Partner with R&D teams to ensure supplier processes support pilot line performance, design validation, and manufacturability goals
- Lead supplier engagement for DFM/DFA initiatives to optimize component design and production efficiency
- Develop and execute supplier improvement programs to drive speed during early NPI phases and ensure long-term reliability
- Build and lead a small high-performing team of supplier engineers focused on NPI execution, technical leadership, and strategic tooling and supplier development
- Influence supplier selection decisions through technical capability assessments and risk-based evaluations
- Interface with equipment vendors and suppliers to support custom tooling, fixtures, and semi-automated process development
- Ensure compliance with FDA regulations, ISO 13485, GMP, and internal quality standards across all supplier activities
- Dual reporting to the VP of Supplier Development Engineering and leadership for NPI programs; ownership of supplier engineering strategy and execution for NPI programs
Requirements
- BS in Mechanical, Industrial, or Manufacturing Engineering with 12+ years of experience in supplier engineering or manufacturing in a regulated industry
- MS in Engineering or Engineering Management with 10+ years of relevant experience preferred
- Expertise in supplier process development, component validation, and tooling qualification
- Demonstrated success in leading supplier engineering efforts for complex NPI projects in regulated environments
- Familiarity with challenges in sourcing and validating molded components, stamped metals, springs, and micro-mechanisms
- Strong project management and cross-functional leadership skills
- Experience with supplier audits, technical capability assessments, and capital tooling deployment
- Experience with Class II medical devices and global supplier networks highly desirable
- Proven ability to lead and develop high-performing technical teams and mentor peers
- Skilled at navigating ambiguity, influencing cross-functional decisions, and communicating across engineering, operations, and supplier teams
- Able to work in a Class 8 Cleanroom Environment as needed
- Willingness to travel up to 25%, including international travel to suppliers and manufacturing sites
- Role based in Acton; ideal candidate will be in office a minimum of 4 days a week