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
- Proficient in Microsoft Office tools: Word, Excel, PowerPoint
- Working knowledge of statistical analysis software; Minitab and/or JMP preferred
- Working Knowledge of CAD Design and print reading; SolidWorks preferred
- Familiar with root cause analysis techniques (DMAIC, DMADV, Fishbone, etc.) and statistical process control (SPC).
- Familiar with experiment design (DOE) and validation techniques (IQ, OQ, TMV, CSV, PQ).
- Comfortable troubleshooting mechanical equipment both Semi and fully automated
- Basic knowledge of common challenges of high-volume component manufacturing methods (i.e. injection molding, stamping, springs, CNC milling/turning, etc.)
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.
- Support project deliverables for installation of new manufacturing equipment, manufacturing equipment upgrades, and new component introductions.
- Identify and implement process improvements to enhance manufacturing efficiency, quality, and cost-effectiveness.
- Monitor and report on critical performance and process metrics; own the required efforts to ensure these KPIs are at or above target.
- Conduct structured root cause investigations using standardized templates and problem-solving tools.
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
