Manager, Manufacturing Engineering, NPI Programs

Responsibilities

• Lead the manufacturing engineering strategy for NPI programs, ensuring alignment with product development milestones and scalability.
• Develop and implement pre-production assembly processes, including manual, semi-automated, and fully automated workstations.
• Scope, budget, and manage capital projects for assembly equipment, including vendor selection, procurement, and installation.
• Drive the transition from pilot builds to full production through process optimization and automation readiness.
• Collaborate with R&D and Supplier Engineering to ensure product designs support DFM/DFA and automation goals.
• Oversee equipment validation processes, including FAT/SAT and IQ/OQ/TMV/PQ.
• Build and lead a high-performing team of manufacturing engineers focused on technical problem-solving and continuous improvement.
• Ensure strict compliance with FDA regulations, ISO 13485, GMP, and internal quality standards.

Requirements

• BS in Mechanical, Industrial, or Manufacturing Engineering.
• 10+ years of experience in manufacturing engineering or automation within a regulated industry.
• Proven leadership or management experience leading technical teams.
• Strong knowledge of DFM/DFA principles.
• Hands-on experience with robotics, vision inspection systems, and PLC/HMI.
• Familiarity with FDA, ISO 13485, and GMP requirements.
• Ability to work onsite in Acton, MA, at least 4 days a week.

Preferred Qualifications

• MS in Engineering or Engineering Management.
• Experience with Class II medical devices and automated assembly systems.

Benefits

• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off (PTO).
• Employee wellness programs.

About the Company

Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. Our flagship Omnipod Insulin Management System provides a unique, wearable, tubeless alternative to traditional insulin delivery methods.