Manufacturing Engineer (Onsite)

Insulet Corporation•Acton, MA

1d•Onsite

About The Position

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.

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.)
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.

Nice To Haves

Experience in the medical device industry is preferred.
High-Volume Manufacturing and/or Automation Experience is a plus.

Responsibilities

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.