James Madden

James Madden is an experienced professional in quality and regulatory affairs, currently serving as Director of Quality & Regulatory Affairs at Viant Medical since September 2018. Prior to this role, James held positions at Integer Holdings Corporation as Quality Manager, and at Accellent as Principal Quality Engineer and Quality System Program Manager, where strategic projects included facility shutdowns and the launch of an ISO 13485 compliant quality system in Malaysia. James has a diverse background in quality engineering, having also worked as a Manufacturing Engineer at ConMED and provided outsourced support as a Quality Engineer at Reglera and Boston Scientific. Early career roles included process and validation engineering at bioMerieux and Pharmaceutical Systems Inc. James earned a Bachelor of Science in Mechanical Engineering from the University of Illinois Urbana-Champaign in 2002.