Associate Manufacturing Engineer, Acton)

About the Role

Join Insulet and play a hands-on role in advancing the manufacturing of the innovative Omnipod® insulin delivery system. This position is ideal for early-career engineers who enjoy solving technical challenges, improving automated manufacturing processes, and working in a highly regulated medical device environment. You'll collaborate with global manufacturing teams, support new equipment installations and validations, drive continuous improvement initiatives, and help ensure world-class quality, efficiency, and reliability.

Key Responsibilities

• Project deliverables for installation of new manufacturing equipment
• Support of capital equipment projects including coordination with suppliers to ensure performance, timing, and budget targets are met
• Assist with equipment validations and continuous improvement activities at CM and at Insulet manufacturing facility
• Drive product and process improvements in support of Insulet’s Operations objectives:
• Best Quality
• Highest Efficiency
• Lowest cost
• Develop and drive Continuous improvement efforts
• Maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing
• Generate validation/qualification (OQ, TMV, CSV, PQ) protocols, coordinate execution, and write final reports
• Author and implement Engineering Change Orders
• Design and coordinate the construction and validation of manufacturing fixtures
• Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support
• Use standardized root cause investigation templates and problem-solving tools to carry out non-conforming material investigations
• Implement corrective and preventive actions
• Monitor and report on yield and equipment up-time information; own efforts to ensure these KPIs are at or above target
• Support new product introduction initiatives
• Travel to key suppliers to help them carry out critical investigations or improvement projects
• Carry out duties in a quality system environment
• Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics
• Interpret the mechanical properties of the selected material for the product design and make recommendations for suitable alternatives
• Performs other duties as required

Requirements & Tech Stack

• Proficient in all Microsoft Office tools
• Excellent Microsoft Excel and Data Analysis Skills
• Working knowledge of Minitab and/or JMP statistical analysis software
• Working Knowledge of Solidworks and print reading
• Proficient in Six Sigma/Lean manufacturing concepts
• Comfortable troubleshooting mechanical equipment both semi and fully automated
• Basic knowledge of common challenges with assembly of molded components, stamped metal, and springs
• Strong command of structured problem-solving tools
• Strong project management skills
• Possesses strong mechanical analysis skills

Qualifications

• B.S. in Mechanical/Industrial/Electrical Engineering or equivalent field, and 0-2 years of engineering manufacturing experience.
• Experience in the medical device industry is preferred.
• High-Volume Manufacturing and/or Automation Experience is a plus.
• The position is in-person at our Acton location.
• Travel is estimated at 5% but will flex depending on business needs.