Jim Rosa provides quality engineering guidance to companies for the development, management and operation of quality systems for devices. He has 40 years of experience leading R&D and quality functions within regulated industries. With roots in research and development and conversion to quality systems oversight later in his career, Jim provides a solid understanding and perspective from engineering and quality in bringing products to market in the medical device and IVD industries. The blend of working with research & development and quality system function, in the EU and US, in startups and large companies provides a unique insight into the practical application of design control for medical devices. Jim also has four patents related to medical device safety system implementations. Jim has worked for Gambro, Intel, Reglera, Dohmen and a number of start-ups such as CeMines (IVD) and FibroTx(IVD).
Jim’s recent focus has been on Systems & Software within the medical device market, driving strategy and implementation efforts for traditional electromechanical, mobile applications, wireless applications, infrastructure software devices, and software as a device. Additionally, Jim has taught Design Controls, V&V, and Risk Management at the University level.
Mr. Rosa has earned degrees from Colorado State University (MBA) and the Radford University (BSCS).