Associate Manufacturing Engineer (Onsite - Acton)

Job Summary

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.

Position Overview

The Associate Manufacturing Engineer, Global Engineering, will be a key team member in the growth and ongoing support of Insulet's manufacturing base across the world, at Contract Manufacturer (CM) sites and at Insulet's US Manufacturing facility in Acton, MA. The candidate will coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new manufacturing equipment and processes.

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 main 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 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 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 selected materials and make recommendations for suitable alternatives

Required Skills and Competencies

• 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

Education and Experience

• High School diploma and 10+ years of practical experience in Engineering in a highly regulated manufacturing environment (e.g. Medical, Aerospace, Automotive)
• 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