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.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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Learn more about this Employer on their Career Site

Manager, Manufacturing Engineering, NPI Programs (Onsite)