Manufacturing Engineer; Onsite - Acton, MA

Manufacturing Engineer

We are seeking a skilled and motivated 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.

• Continuous Improvement:
  Develop and drive continuous improvement efforts for manufacturing processes and equipment.
• Manufacturing Expansion:
  Support project deliverables for installation of new manufacturing equipment, manufacturing equipment upgrades, and new component introductions across various Insulet manufacturing sites
• 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.

• Proficient in Microsoft Office tools:
  Word, Excel, Power Point
• Working knowledge of statistical analysis software;
  Minitab and/or JMP preferred
• Working Knowledge of CAD Design and print reading;
  Solid Works 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.)

• 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.

• The primary location for this position is in-person at our Acton location.
• Travel is estimated at 30-40%, primarily international, but will flex based on business needs.