Manager, Manufacturing Engineering, NPI Programs (Onsite)

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
• Key Decision Rights:
• Ownership of assembly equipment strategy and execution for a key NPI program
• Ownership of capital equipment planning, procurement, and validation for assembly processes
• Decision-making on process design, automation strategy, and transition planning from pilot to production
• Required Leadership/Interpersonal Skills & Behaviors:
• Strategic thinker with the ability to translate product requirements into scalable manufacturing solutions
• Strong communicator and collaborator across engineering, operations, and vendor teams
• Proven ability to lead and develop high-performing technical teams
• Experience mentoring peers and promoting a culture of innovation and continuous improvement
• Skilled at navigating ambiguity and driving clarity in fast-paced, early development environments
• Demonstrated ability to influence decisions and outcomes across organizational boundaries
• Required Skills and Competencies:
• 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
• Education and Experience:
• BS in Mechanical, Industrial, or Manufacturing Engineering with 10+ years of experience in manufacturing engineering or automation in a regulated industry
• 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
• Prior leadership and/or management experience is required
• Experience with Class II medical devices and automated assembly systems is highly desirable
• Additional Information:
• Able to work in a Class 8 Cleanroom Environment as needed
• Role is based in Acton and the ideal candidate will be in office a minimum of 4 days a week
• Travel up to 10%, including international travel to equipment vendors and manufacturing sites
• NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
• Additional Information:
• Compensation & Benefits:
• For U.S.-based positions only, the an

Benefits

Additional Information

Job Summary As the Manager of Manufacturing Engineering for NPI Programs, you'll lead the end-to-end development of assembly processes-from hands-on prototype builds to cutting-edge automated lines. You'll partner closely with R&D, supplier engineering, and operations to design scalable, high-performance manufacturing solutions that support successful product launches and long-term growth. Position Overview: The Manager, Manufacturing Engineering, NPI Programs 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.

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