Collaborative, dynamic, multi-discipline product development leader with a driven focus on delivering break-through technologies & innovative products that address unmet clinical and marketplace needs in order to create consistent, superior long-term R&D ROI for the sponsoring business. Deep expertise in extracorporeal blood pumping systems designed to help heart and kidney functions.PROFILE: Dynamic, creative, high energy product development professional with significant experience building and leading fast-paced, high-output, multi-discipline medical and biotech R&D teams.  Strong passion for developing and implementing powerful “first principles” based milestone engineering processes that produce consistently superior product development results.  Twenty-plus years experience of sophisticated systems development requiring successful integration of electrical, software, plastics, mechanical, chemical and biologic constituents that meet, or exceed, unmet clinician and marketplace needs.  Proven track record of building strong collaborations with key Marketing, Sales, Manufacturing, Quality, Regulatory, and Clinical functions.  Experienced leader of open, spirited, collaborative culture that encourages and rewards highest performance of a diverse team and its members and provides exceptional sustained individual motivation and satisfaction. Well versed in cultivating strong clinician relationships with engineering that result in improved overall R&D effectiveness. Extensive expertise in blood and sterile fluid pumping systems for home, OR and ICU settings. Experienced with creation of Design Control procedures and systems that satisfy FDA and CE requirements as well as support successful clinical trials and FDA evaluations and audits. Encourage and ingrain appropriate “spirit of innovation” throughout organization.  Unique experience as co-instructor/alumni mentor of MIT senior Mechanical Engineering course (2.009).