Focused Professional Engineer providing integration of design and reliability for rapid development of novel devices for the medical device industry. Passionate about facilitating communication across the full range of stakeholders in the development process – inventors, physicians, medical professionals, manufacturing, custom test engineers, designers, quality, regulatory, finance, and marketing. Expertise in design control, risk management, product and process validation activities, sterilization, and design specifications in compliance with EN ISO 13485 and EN ISO 14971 standards. Experience with stents, catheters, and other implantable and disposable products.