Sr. Mechanical Engineer -Disposables
Core
Design and lifecycle management of injection-molded plastic disposable fluid-path components for urology medical devices.
Role type
Senior Mechanical Engineer (Medical Devices)
Builds
Cartridges, cassettes, tubing systems, connectors, sealing interfaces, and locking mechanisms.
Domain
Medical Devices / Urology / Injection Molding
Deliverable
production ML models | product features
Required skills
Injection-molding design principles, 3D modeling, GD&T, tolerance analysis, supplier collaboration, root-cause analysis, design verification testing, design controls, risk management.
Preferred skills
Plastic material selection, process validation, FDA/ISO 13485 knowledge, statistics, design of experiments, field investigation experience.
Technologies
CAD, GD&T, PPAP, FDA regulations, ISO 13485
Responsibilities
Translate customer needs into engineering requirements, develop 3D models and drawings, lead supplier technical collaboration, execute design verification testing, investigate field issues, maintain design documentation.
Seniority
Senior, hands-on IC