Global Equipment Engineering Manager
Role Overview
The Manager, Global Equipment Engineering leads the development and scale-up of assembly processes for new medical device products. This role is responsible for moving products from early manual builds to semi-automated and fully automated production, ensuring manufacturing systems are efficient, validated, and ready for launch and growth.
Working closely with R&D, Manufacturing Engineering, Supplier Engineering, and Operations, this leader oversees pre-production assembly capabilities, equipment strategy, and automation planning to support new product introductions (NPI).
Key Responsibilities
- Lead manufacturing engineering strategy for NPI programs, aligned with product development milestones
- Develop manual and semi-automated assembly processes for early builds and pilot production
- Plan and manage capital equipment projects, including budgeting, vendor selection, purchasing, installation, and validation
- Drive the transition from pilot builds to full production through process optimization and automation
- Partner with R&D and Supplier Engineering to ensure designs support manufacturability and automation (DFM/DFA)
- Lead development and validation of automated assembly lines, including FAT/SAT and IQ/OQ/PQ
- Build and manage a team of manufacturing engineers supporting NPI and continuous improvement
- Ensure compliance with FDA regulations, ISO 13485, GMP, and internal quality standards
Required Skills & Experience
- Deep experience in assembly process development and manufacturing automation
- Proven success leading capital equipment projects and scaling production
- Strong knowledge of DFM/DFA principles
- Experience with automated equipment, including robotics, vision systems, and PLC/HMI
- Solid project management and cross-functional leadership skills
- Experience working in regulated manufacturing environments
Education
- BS in Mechanical, Manufacturing, or Industrial Engineering with 10+ years of experience
- MS preferred with 8+ years of relevant experience
- Prior people-management experience required
- Experience with Class II medical devices and automated assembly is highly desirable
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