Senior Manufacturing Engineer (Onsite - Acton)
Core
Lead manufacturing excellence, process improvements, and new product introductions for high-volume, automated production of electro-mechanical medical devices.
Role type
Senior Manufacturing Engineer
Builds
Electro-mechanical medical devices (Omnipod platform)
Domain
Medical device manufacturing / High-volume automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Lean Six Sigma, statistical process control, design of experiments (DOE), validation techniques, root cause analysis, project management, mechanical troubleshooting, print reading, data analysis
Preferred skills
Medical device industry experience, high-volume manufacturing, automation experience
Technologies
Minitab, JMP, Solidworks, Microsoft Excel
Responsibilities
Develop and drive continuous improvement efforts for manufacturing processes and equipment; Lead project deliverables for installation of new manufacturing equipment and upgrades; Establish, monitor, and report on critical performance and process metrics; Lead and conduct structured root cause investigations; Manage all project phases from concept to implementation; Develop and execute validation protocols (IQ, OQ, PQ) for processes and equipment; Maintain accurate documentation of processes and validation activities per GDP practices.
Seniority
Senior, hands-on IC