Insulet Corporation
Manager, Global Equipment Engineering (Hybrid)
Insulet Corporation, Acton, Massachusetts, us, 01720
Manager, Global Equipment Engineering
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid Position Overview: The Manager, Global Equipment Engineering 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 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 is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid Position Overview: The Manager, Global Equipment Engineering 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 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