Manufacturing Engineer II - Sustaining Engineering
Core
Develop, sustain, and improve production fixtures, equipment, and manufacturing processes for Extracorporeal Life Support (ECLS) products and catheters.
Role type
Manufacturing Engineer II (Sustaining Engineering)
Builds
Production fixtures, equipment, and manufacturing processes for ECLS products and catheters
Domain
Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DOE, SPC, hypothesis testing, capability studies, Gemba walks, lean manufacturing tools, root cause analysis, corrective action implementation, process validation (IQ/OQ/PQ), equipment specification, work instruction development, project management
Preferred skills
Medical device industry experience, Quality System documentation, manufacturing automation, vision systems, PLC-controlled equipment, technical drawing interpretation, cross-functional project leadership
Technologies
DOE, SPC, IQ/OQ/PQ, PLC, vision systems
Responsibilities
Collaborate with cross-functional teams to identify process improvement opportunities; Apply technical skills and tools to perform in-depth analysis and determine root cause; Identify process improvement opportunities including new fixturing and equipment; Develop shop floor work instructions and train operators; Work with equipment suppliers to develop processes and specifications; Specify and purchase equipment; Create test plans and reports; Execute validation activities (IQ/OQ/PQ); Manage project timelines and scope; Sustain current production through day-to-day support
Seniority
Mid-level, hands-on IC