Director, Advance Manufacturing Engineering (Onsite)

Insulet Corporation•Acton, MA

2d•Onsite

About The Position

The Director of Advanced Manufacturing Engineering will lead the development and execution of next-generation manufacturing technologies for a high-volume, fully automated medical device production & operations. This role is pivotal in shaping the future of manufacturing at scale, driving innovation in automation, tooling, metrology, inline testing for the pod manufacturing process and in the supplier component tooling for injection molding and stamping. The successful candidate will build and lead a high-performing engineering team focused on concept generation, quality improvement, manufacturing design excellence, and operational efficiency.

Requirements

Proven track record of building and leading high-performing engineering teams.
Expertise in automation, tooling design, metrology, inline testing, and component tooling (injection molding & stamping).
Excellent leadership and project management skills.
Exceptional communication and stakeholder management skills, with experience presenting to executive leadership.
Bachelor’s degree in Mechanical, Electrical, or a related engineering field with 15+ years of relevant experience, or a Master’s degree with 10+ years of experience in high‑volume, automated manufacturing.
Minimum of 10 years of people‑management experience, including managing cross‑functional technical teams of approximately 10 or more individuals.

Nice To Haves

Experience with FDA regulations and related medical device regulatory frameworks and strong understanding of regulatory requirements (e.g., FDA, ISO 13485).
Deep understanding of medical device manufacturing processes and associated regulatory considerations.

Responsibilities

Strategic Leadership Build and lead a world-class Advanced Manufacturing Engineering (AME) cross- functional team with disciplines in MFG Engineering, Machine Design & Controls engineering.
Define and execute the vision for next-generation automation and manufacturing technologies Collaborate cross-functionally with Global MFG Engineering, Operations, Quality, Supply Chain & R&D to ensure seamless design transfer and manufacturability
Technology Innovation Drive concept development for advanced automation, tooling, metrology, and inline testing systems specifically focused on increased production speeds, improved inline inspections, and next generation feed systems.
Lead innovation in component tooling strategies for injection molding and stamping processes.
Champion the use of statistical modeling, systems thinking, and data analytics in engineering solutions.
Process Development & Validation innovation development with process validation improvements including IQ, OQ, TMV & PQ.
Ensure robust design for manufacturing (DFM) and process scalability across global sites.
Operational Excellence Establish KPIs and drive manufacturing performance improvements aligned with business goals.
Ensure compliance with regulatory standards and quality systems (e.g., FDA, ISO 13485).
Global Collaboration Provide technical leadership and support to global automation partnerships in the development of next generation manufacturing systems.