Senior Manufacturing Process Engineer
Core
Lead manufacturing process improvements, automation initiatives, capital projects, and operational excellence programs in a regulated medical device environment.
Role type
Senior Manufacturing Process Engineer (Technical Leader)
Builds
High-speed automated assembly systems, medical devices, and optimized production capacity
Domain
Medical Technology / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Lean Manufacturing, Six Sigma, root cause analysis, statistical process control, OEE analysis, capital project management, mechanical troubleshooting, process validation, change management
Preferred skills
FDA-regulated facility experience, ISO 13485 compliance, Lean certification, Six Sigma Green/Black Belt, validation protocols (IQ/OQ/PQ)
Technologies
Servo-controlled equipment, pneumatic systems, cam-driven equipment, automated assembly platforms
Responsibilities
Lead Lean Manufacturing and Continuous Improvement initiatives; Design, troubleshoot, and optimize automated assembly equipment; Lead capital equipment projects from concept to production release; Provide technical leadership for daily manufacturing operations; Train operators and technicians on new processes and equipment
Seniority
Senior, hands-on IC with strategic leadership
