Manager, Global Equipment Engineering (Onsite)
About The Position
The Manager, Global Equipment Engineering is responsible for developing and scaling assembly processes for new products. This role leads the transition from early manual builds to semi-automated, and ultimately fully automated production, ensuring efficient, validated manufacturing systems are in place to support product launch and growth. Working closely with R&D, Manufacturing Engineering, Supplier Engineering, and Operations, this individual will lead the development of pre-production assembly capabilities, including scoping, budgeting, purchasing, installing, and validating equipment serving various stages of product development. A critical responsibility is to define and execute the strategy for scaling manufacturing capacity and transitioning to automated assembly lines that meet quality, performance, and safety requirements.
Requirements
- Expertise in assembly process development, equipment validation, and automation strategy
- Demonstrated success in leading capital projects and scaling manufacturing for complex NPI programs
- Strong understanding of DFM/DFA principles and their application in automated assembly environments
- Experience with semi-automated and fully automated equipment, including knowledge of robotics, vision inspection systems, and PLC/HMI
- Strong project management and cross-functional leadership skills
- Familiarity with regulated manufacturing environments and quality system requirements
- BS in Mechanical, Industrial, or Manufacturing Engineering with 10+ years of experience in manufacturing engineering or automation in a regulated industry
- Prior leadership and/or management experience is required
Nice To Haves
- MS in Engineering or Engineering Management with 8+ years of relevant experience preferred
- Experience with Class II medical devices and automated assembly systems is highly desirable
- Experience with Class II medical devices and automated assembly systems is highly desirable
Responsibilities
- Own and lead the manufacturing engineering strategy for NPI programs, ensuring alignment with product development milestones and production scalability
- Develop and implement pre-production assembly processes, including manual and semi-automated workstations to support feasibility builds and pilot production
- Scope, budget, and manage capital projects for semi-automated and automated assembly equipment, including vendor selection, procurement, installation, and validation
- Lead cross-functional efforts to define and execute the transition from pilot builds to full production, including process optimization and automation readiness
- Collaborate with R&D and Supplier Engineering to ensure product designs support manufacturability (DFM/DFA) and automation goals
- Drive the development and validation of the first automated assembly lines, including equipment specifications, buy off strategy (FAT/SAT), and validation (IQ/OQ/TMV/PQ)
- Build and lead a high-performing team of manufacturing engineers focused on NPI execution, technical problem-solving, and continuous improvement
- Ensure compliance with FDA regulations, ISO 13485, GMP, and internal quality standards across all manufacturing engineering activities
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
