Manufacturing Engineer
Core
Develop new production lines and optimize manufacturing processes for FDA-regulated enteral feeding and infusion pumps to enhance profitability and ensure repeatable, lean production.
Role type
Manufacturing Engineer (Medical Devices)
Builds
Production lines, tools, equipment, and documentation for medical infusion systems
Domain
Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis, Design of Experiments, Fixture design, Root cause analysis, Lean manufacturing (Kaizen, Gemba), Engineering Change Management, Validation activities (IQ/OQ/PQ), Capital project management, Technical writing for regulated environments
Preferred skills
3D modeling (Solidworks), Electronics principles (Basic/Digital/Analog), BOM management, Negotiation, Leadership in automation projects
Technologies
Solidworks, 3D modeling software
Responsibilities
Resolve production issues and field failures; Design and optimize tools and equipment; Support lean manufacturing efforts; Manage Engineering Change Notices; Execute validation activities; Establish preventive maintenance programs; Oversee capital projects; Present project updates to leadership
Seniority
Mid-level, hands-on IC