Associate Manufacturing Engineer (Onsite - 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. This is an excellent opportunity to build expertise in automation, process engineering, Lean/Six Sigma methodologies, and medical device manufacturing while making a meaningful impact on patients' lives.

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

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 use knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new manufacturing equipment and processes. The person will be responsible for KPIs for project budget and timing, as well as machine up-time, process yield and efficiency once equipment is in production. As part of providing support to the Manufacturing Engineering Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work instructions, SOPs, non-conforming material investigations, and tool files.

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 three main objectives: Best Quality, Highest Efficiency, Lowest cost
• Develop and drive Continuous improvement efforts
• At all times 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 the execution of the validation/qualification protocols and write validation/qualification 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 the required 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
• Possesses strong mechanical analysis skills
• 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

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

Skills

• 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

Benefits

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

Pay

Annual base salary range: $65,100.00 - $97,650.00. This position may also be eligible for incentive compensation. Actual pay depends on skills, experience, and education.

Schedule

This position requires on-site working at the Acton, MA location. Travel is estimated at 5% but will flex depending on business needs.