Senior Design Quality Engineer - Irvine
Core
Design Quality Engineer contributing to the technical design and performance of life-saving neurovascular medical devices.
Role type
Senior IC Design Quality Engineer
Builds
Neurovascular devices for stroke, brain aneurysms, and vascular disorders
Domain
Medical Devices / Neurovascular
Required skills
Reliability engineering, Design of Experiments (DOE), Statistical Process Control (SPC), Risk Management, Design for Manufacturability (DFM), Validation & Verification, Root Cause Analysis
Preferred skills
Six Sigma, LEAN, Advanced Statistics (Minitab), ISO13485, FDA QSR, EU MDR, Material Engineering (Metals/Polymers), Requirements Flow-down
Technologies
Minitab, DOE tools, Risk Management tools
Responsibilities
Conduct technical reliability studies and evaluations of engineering design concepts; Develop and coordinate reliability engineering programs; Identify and manage risk throughout the product lifecycle; Analyze performance reports and process control statistics; Propose design or formulation changes to improve system reliability; Oversee Validation & Verification activities; Mentor other engineers.
Seniority
Senior, hands-on IC
