Scientific Advisor and Senior Manager of Technology with 23 years of experience in the development, launch and adoption of novel technologies in the medical device space. Proven track record of monitoring and reporting on emerging technologies, taking laboratory concepts into product development, designing test methods for biological evaluation, transferring prototype designs into Manufacturing, obtaining FDA regulatory approvals, and launching product to market. Competency at effective collaboration as Project Manager with Engineering, Regulatory Affairs, Operations, Manufacturing, Sales and Marketing teams in the development and launch of new technologies, and implementation of improvements to existing products. Proficient in executing Design Control. Extensive experience in supporting Regulatory Affairs in interfacing with FDA to receive clearances for product technologies and new test methods. Proven success in the launch and widespread adoption of new products. Expertise includes project management per Design Control standards to achieve successful product transfer to Manufacturing and FDA clearance of pipeline products. Proven track record in the development and commercialization of cutting-edge biologics and medical devices via strategic thinking and effective leadership of Project teams. Possess a strong ability to overcome complex issues during the processes of product development, operations transfer, and regulatory approval. Excellent understanding of design control, industry and regulatory standards, and paths required for clearance of medical devices and biologics. Extensive experience in project managing cross-functional teams to achieve corporate objectives. Adept at monitoring emerging technologies and preparing technical and feasibility summaries for internal customers. Extensive experience in presenting to investors, hospital administrators, companies, and key opinion leaders to drive the adoption of the company’s technologies.