Manager, Manufacturing Engineering, NPI Programs (Onsite)

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. 

 

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 annual base salary range for this role is $122,600.00 - $183,950.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.