Senior Manufacturing Engineer (Onsite - Acton)
About The Position
Take the lead in driving manufacturing excellence for Insulet’s innovative Omnipod® platform in a highly automated, high-volume medical device environment. This role offers the opportunity to lead process improvements, equipment validations, new product introductions, and continuous improvement initiatives that directly impact product quality, efficiency, and patient outcomes. Ideal for engineers with strong Lean Six Sigma, statistical analysis, automation troubleshooting, and project management expertise, this position provides the chance to work cross-functionally with Operations, Quality, Controls, and Engineering teams while supporting cutting-edge manufacturing technologies in a fast-growing global organization committed to improving the lives of people with diabetes.
Requirements
- 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 experience.
- M.S. in Engineering or Engineering Management, with 3+ years of experience.
- 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
Nice To Haves
- Experience in the medical device industry is preferred.
- High-Volume Manufacturing and/or Automation Experience is a plus.
Responsibilities
- Develop and drive continuous improvement efforts for manufacturing processes and equipment.
- Lead project deliverables for installation of new manufacturing equipment, manufacturing equipment upgrades, and new component introductions.
- Drive product and process improvements to support the company's objectives of best quality, highest efficiency, and lowest cost.
- 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.
- Lead and conduct structured root cause investigations using standardized templates and problem-solving tools.
- Manage all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
- Develop and execute validation (IQ, OQ, TMV, CSV, PQ) protocols for new and existing processes and equipment. Write validation/qualification reports.
- Work closely with Maintenance, Equipment Design, Controls, Operations, and Quality teams to ensure seamless production and continuous improvement.
- 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).
- Maintain a cGMP compliant environment and operate within FDA and ISO guidelines for Class II Medical Device manufacturing.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- Additional employee wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
