Senior Consumables Engineer
Core
Design, development, and continuous improvement of disposable medical devices and consumables for a hemodialysis system.
Role type
Senior IC mechanical engineer (medical device disposables)
Builds
High-volume disposable consumables and accessories for the Tablo Hemodialysis System
Domain
Medical devices / Dialysis / Manufacturing
Required skills
Mechanical engineering, 3D CAD (Solidworks), injection molding, ultrasonic welding, process validation (PPAP, IQ, OQ, PQ), statistical analysis (Minitab, DOE), cleanroom assembly, sterilization, root cause analysis
Preferred skills
Six-Sigma Green/Black Belt, experience with blood-contacting products, high-volume consumables interfacing with capital equipment
Technologies
Solidworks, Minitab, injection molding, ultrasonic welding, sterilization equipment
Responsibilities
Create 3D CAD and 2D drawings for low-cost manufacturing; validate supplier processes (molding, extrusion, sterilization); develop assembly and testing protocols; perform verification and validation testing; troubleshoot manufacturing issues; generate design documentation for FDA/ISO compliance.
Seniority
Senior, hands-on IC