Manufacturing Engineer 3
Core
Drive Lean tool implementation and continuous improvement for manufacturing precision instruments for minimally invasive robotic surgery.
Role type
Senior Manufacturing Engineer (Medical Devices)
Builds
Production tooling/fixtures, manufacturing equipment, and design improvements for robotic surgery systems.
Domain
Medical device manufacturing / Robotic surgery
Required skills
Lean manufacturing, Root Cause Analysis, FMEA, CAD Software, Statistical analysis, Engineering/Technical Drawings review, Supplier quality management, Process Improvement, Equipment validation, ECO management
Preferred skills
FDA Quality System Regulation, ISO 13485, Mid/high volume complex mechanism manufacturing, Process Development, Equipment Validation, Mfg. Scale-up, US-Mexico supply chain knowledge
Technologies
CAD Software, Manufacturing Execution Systems (implied via MPIs/DFM), Equipment Qualification tools
Responsibilities
Evaluate and challenge mechanism designs for manufacturability; Approve design releases and review engineering documentation; Develop and maintain compliance with quality systems; Update Manufacturing Process Instructions (MPIs); Address line support issues and document variances; Drive improvements in safety, quality, production, and cost; Define Preventive Maintenance and calibration procedures; Execute Equipment Qualification Reports; Interface with external vendors for service and calibration.
Seniority
Senior, hands-on IC