Manager, Global Equipment Engineering

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