Senior Manufacturing Engineer (Onsite)

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

We are seeking a skilled and motivated Senior Manufacturing Engineer to join our dynamic team. The ideal candidate will have experience in a high-volume, highly automated manufacturing environment and will be responsible for ensuring the efficient production of our electro-mechanical medical devices. This role requires a strong background in problem-solving techniques, root cause analysis, lean methodologies, statistical process control, design of experiments (DOE), and validation techniques.

Responsibilities:

• Continuous Improvement: Develop and drive continuous improvement efforts for manufacturing processes and equipment.
• New Product Introduction: Lead project deliverables for installation of new manufacturing equipment, manufacturing equipment upgrades, and new component introductions.
• Process Improvement: Drive product and process improvements to support the company's objectives of best quality, highest efficiency, and lowest cost.
• Key Performance Indicators: Establish, Monitor, and Report on critical performance and process metrics; own the required efforts to ensure these KPIs are at or above target. At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
• Root Cause Analysis: Lead and conduct structured root cause investigations using standardized templates and problem-solving tools.
• Project Management: Manage all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
• Validation: Develop and execute validation (IQ, OQ, TMV, CSV, PQ) protocols for new and existing processes and equipment. Write validation/qualification reports.
• Cross-Functional Collaboration: Work closely with Maintenance, Equipment Design, Controls, Operations, and Quality teams to ensure seamless production and continuous improvement.
• Documentation: Maintain accurate and detailed documentation of processes, experiments, and validation activities per industry GDP practices. Manage all documentation within Insulet Digital Systems (QMS, PLM, PDM).
• Compliance: Maintain a cGMP compliant environment and operate within FDA and ISO guidelines for Class II Medical Device manufacturing.

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 5+ years of manufacturing experience.
• M.S. in Engineering or Engineering Management, with 3+ years of manufacturing experience.
• Experience in the medical device industry is preferred. High-Volume Manufacturing and/or Automation Experience is a plus.

Additional Information

• The position requires on-site working at the Acton site.

Up to 5% travel required; Ability to travel internationally (North America and APAC)

• NOTE: This position requires on-site working (requires on-site o