Staff Automation Engineer NPI

The Staff Engineer, Global Equipment Engineering is a senior technical leader responsible for developing and scaling manufacturing equipment and processes for new product introductions, from early feasibility and pilot builds through fully automated, high-volume production. This role drives equipment strategy, automation, and capital projects while ensuring manufacturing solutions are reliable, compliant, and aligned with global business objectives. The ideal candidate has deep expertise in automated assembly systems, equipment validation, and regulated manufacturing environments, along with a proven track record of leading complex cross-functional programs and influencing technical decisions across multiple sites and suppliers. Based in Acton, MA, this position requires strong leadership, mentoring, and collaboration skills to support global manufacturing growth and innovation.

The Staff Engineer, Global Equipment Engineering is a senior individual contributor who defines and delivers scalable manufacturing equipment and process solutions for new products, from early feasibility and manual assembly through pilot production, automation, and high-volume manufacturing. The role provides technical direction across functions and sites, shapes major equipment and investment decisions, and ensures solutions are robust, compliant, and aligned with global manufacturing strategy.

• ◆Lead manufacturing process and equipment development for complex new product introduction programs, aligning technical execution with program, quality, and production goals.
• ◆Define scalable assembly strategies and technical roadmaps spanning manual, semi-automated, and fully automated production.
• ◆Own the technical definition and execution of major capital equipment projects, including requirements, vendor strategy, design reviews, acceptance, validation, and production handoff.
• ◆Establish equipment and process architectures, engineering standards, and reusable approaches that improve scalability, reliability, and consistency across programs and sites.
• ◆Influence product and process design through DFM/DFA to improve manufacturability, automation readiness, serviceability, and process capability.
• ◆Approve critical equipment specifications, acceptance criteria, and risk-based validation strategies, including FAT, SAT, IQ, OQ, TMV, and PQ.
• ◆Direct resolution of complex technical risks and issues across equipment, process, controls, quality, and operations.
• ◆Make and communicate technical recommendations on equipment architecture, vendor selection, automation strategy, capital priorities, and manufacturing scale-up.
• ◆Ensure equipment and process solutions meet applicable regulatory, quality, safety, and cybersecurity requirements.
• ◆Mentor engineers and strengthen technical capability through coaching, design reviews, and constructive challenge.

Basic

• ✓Bachelor’s degree in mechanical, Industrial, Manufacturing, Electrical, Automation, or a related engineering discipline.
• ✓12+ years of relevant experience in manufacturing engineering, equipment engineering, or automation within a regulated industry.
• ✓Demonstrated experience leading complex capital equipment programs from

through validation and production handoff.

• ✓Demonstrated expertise in automated assembly equipment and integration, including robotics, motion control, vision, sensing, PLC/HMI, or manufacturing data systems.
• ✓Working knowledge of regulated manufacturing requirements, including equipment validation, design controls, risk management, and change control.

• ✓Master's degree in engineering or engineering management.
• ✓Experience with Class II medical device manufacturing.
• ✓Experience scaling manufacturing from early feasibility or pilot builds through high-volume automated production.
• ✓Experience applying DFM/DFA and process capability methods to automated assembly systems.
• ✓Experience leading technical decisions across multiple functions, suppliers, and manufacturing sites.