Associate Manufacturing Engineer (Onsite - Acton)

Insulet Corporation; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Insulet Corporation in Acton, MA seeks an Associate Manufacturing Engineer to help scale Omnipod® manufacturing. You will work hands-on with automated processes, coordinate equipment installations, validations, and continuous improvement within a regulated medical device environment.

The role emphasizes problem-solving, manufacturing fixture design, and cross-functional collaboration with CM sites and Insulet teams to ensure high quality, yield, and efficiency across global operations.

Qualifications

• Proficient with MS Office tools and data analysis
• Experience with statistical analysis software (Minitab/JMP)
• SolidWorks proficiency and ability to read engineering prints
• Familiarity with Six Sigma/Lean manufacturing concepts
• Strong problem solving and mechanical reasoning skills

Responsibilities

• Install new manufacturing equipment and deliver project milestones
• Assist with equipment validations and continuous improvement activities
• Drive product and process improvements to improve quality, efficiency and cost
• Maintain a cGMP compliant environment per FDA guidelines for Class II medical devices
• Create and coordinate validation/qualification protocols and final reports
• Draft and implement Engineering Change Orders
• Design and validate manufacturing fixtures and tooling
• Lead root cause investigations using structured problem-solving templates
• Implement corrective and preventive actions and monitor KPIs
• Support new product introductions and supplier collaborations
• Travel to key suppliers for investigations or improvement projects
• Perform mechanical analyses and assess material properties for designs

Skills

Excel

Data analysis

Minitab/JMP

SolidWorks

Six Sigma/Lean

Microsoft Office

Mechanical troubleshooting

Tools

Minitab

JMP

SolidWorks

Printer reading/blueprints

Job description

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. 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.

Company Overview

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.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

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 use his/her 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
• Supportof…some text no?
• 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(3) 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
• undefined

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 mec