Manufacturing Engineer (Onsite - Acton)
Core
Lead manufacturing excellence for Insulet's Omnipod® platform in a highly automated, high-volume medical device environment, driving process improvements, equipment validations, and new product introductions.
Role type
Manufacturing Engineer (Medical Devices)
Builds
Electro-mechanical medical devices (Omnipod insulin delivery systems)
Domain
Medical Devices / High-Volume Manufacturing / Automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Lean Six Sigma, statistical analysis, automation troubleshooting, project management, root cause analysis, statistical process control (SPC), design of experiments (DOE), validation techniques (IQ, OQ, PQ), cGMP compliance
Preferred skills
Minitab/JMP, SolidWorks, injection molding, stamping, CNC milling/turning
Technologies
Microsoft Office, Minitab, JMP, SolidWorks
Responsibilities
Develop and drive continuous improvement efforts for manufacturing processes and equipment; Support project deliverables for installation of new manufacturing equipment and upgrades; Identify and implement process improvements to enhance efficiency and quality; Monitor and report on critical performance and process metrics; Conduct structured root cause investigations using standardized templates; Develop and execute validation protocols for new and existing processes and equipment; Work cross-functionally with Maintenance, Equipment Design, Controls, Operations, and Quality teams; Maintain accurate documentation of processes and validation activities per industry GDP practices
Seniority
Mid-Senior level (7+ years experience or Bachelor's + 2 years)