Manufacturing Engineer (Onsite - Acton)
About the role
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.
Responsibilities
- Continuous Improvement: Develop and drive continuous improvement efforts for manufacturing processes and equipment.
- New Product Introduction: Support project deliverables for installation of new manufacturing equipment, manufacturing equipment upgrades, and new component introductions.
- Process Improvement: Identify and implement process improvements to enhance manufacturing efficiency, quality, and cost-effectiveness.
- Key Performance Indicators: Monitor and report on critical performance and process metrics; own the required efforts to ensure these KPIs are at or above target.
- Root Cause Analysis: Conduct structured root cause investigations using standardized templates and problem-solving tools.
- 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.
Requirements
Required Skills And Competencies:
- 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.)
Education And Experience:
- High School diploma and 7+ years of practical experience in Engineering in a highly regulated manufacturing environment (e.g. Medical, Aerospace, Automotive) or
- Bachelor’s degree in manufacturing engineering, mechanical engineering, or a related field and 2+ years of experience or
- M.S. in Engineering or Engineering Management, with 0-2 years of experience
- Experience in the medical device industry is preferred.
- High-Volume Manufacturing and/or Automation Experience is a plus.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- Additional employee wellness programs
Pay
For U.S.-based positions only, the annual base salary range for this role is $76,400.00 - $114,575.00. This position may also be eligible for incentive compensation. Actual pay depends on skills, experience, and education.
Schedule
The position is in-person at our Acton location. Travel is estimated at 30-40% but will flex depending on business needs. This position requires on-site working (requires on-site office/plant/lab work).