Associate Manufacturing Engineer

Responsibilities

• Support the installation of new manufacturing equipment and capital projects, ensuring targets for performance, timing, and budget are met
• Assist with equipment validations (OQ, TMV, CSV, PQ) and continuous improvement activities at both contract manufacturer and Insulet sites
• Drive product and process improvements to optimize quality, efficiency, and cost
• Maintain a cGMP compliant environment in accordance with FDA guidelines for Class II Medical Device manufacturing
• Author and implement Engineering Change Orders, work instructions, SOPs, and validation reports
• Design and coordinate the construction and validation of manufacturing fixtures
• Perform root cause investigations using structured problem-solving tools to address non-conforming materials
• Monitor and report on key performance indicators including yield and equipment up-time
• Travel to manufacturing sites and key suppliers as required (up to 50% travel)

Requirements

• B.S. in Mechanical Engineering and 2+ years of medical device experience, OR
• M.S. in Mechanical, Industrial, or Engineering Management with 1 year of experience

Preferred Qualifications

• Proficiency in Solidworks and drafting skills
• Strong data analysis skills using Microsoft Excel, Minitab, or JMP
• Knowledge of Six Sigma and Lean manufacturing concepts
• Experience troubleshooting semi-automated and fully automated mechanical equipment
• Strong project management and structured problem-solving skills
• Excellent written and verbal communication skills

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. The Omnipod Insulin Management System provides a unique, wearable, tubeless alternative to traditional insulin delivery methods.