design-validation jobs in San Diego

As a Development Sr Engineer II, you will serve as a design owner and project manager for new medical device product design, development, and commercialization in the orthopedic/arthroplasty space. You will translate user needs from surgeons into design requirements, create CAD models and design documentation, conduct design verification/validation testing, and support regulatory and manufacturing teams through product launch.…See more The role demands expertise in parametric CAD modeling, finite element analysis, design of experiments, and medical device regulations and standards.

This role leads quality engineering strategy and operations for a medical device design center, overseeing compliance with FDA regulations (21 CFR 820, ISO 13485, ISO 14971) and managing a team of Quality Engineers. The manager develops and sustains quality management systems, executes quality initiatives, provides statistical and design-control expertise, and drives continuous improvement.…See more The position requires ten years of progressive QA experience in FDA-regulated industries, three years of direct management experience, and deep knowledge of design controls, risk management, and quality engineering methodologies.