Brian Dey

Background

About Brian Dey

Over twenty years of diverse engineering experience from novel optical fiber material development and scale up manufacturing to packaging engineering for medical devices and surgical instrumentation. Successfully leveraged technical expertise and project management skills to enable timely development, submission, and launch of over 700 packaging designs and testing of over instruments while following cGMP, EU MDR, and FDA regulations including 21 CFR Part 11 Validation and 21 CFR 820,30 Design Control. Demonstrated hands-on expertise in validation, sterilization, and reprocessing protocols. Operated with minimal supervision to create and implement company Quality Management System (QMS) and successfully achieve ISO 9001:2015 certification. Dedicated and integral member of multiple cross-functional teams and successfully communicated with a broad range of external partners including customers, surgeons, suppliers, contract manufacturers, and testing facilities.