A strategically focused leader in R&D and product development with a strong track record of successful medical technology innovations and product commercialization. Demonstrates proven R&D and cross-functional leadership balanced with solid business and organizational management experience. Has held leadership positions in both large organizations and fast-paced environments, effectively managing organizations with complex reporting structures through situational leadership. Successfully built teams, developed employees, and established core competencies critical to achieving business goals. Directed multiple product development teams concurrently and developed technology roadmaps and annual operating plans. Strengths include leadership, planning, turnarounds, execution, and new product development.Medical technology experience includes interventional, surgical, transcatheter, endoscopic, energy-based, and other minimally invasive technologies, supported by foundational knowledge in mechanical engineering, structural mechanics, and computational analysis. Device development experience spans cardiovascular, cardiac surgery, orthopedic, and other vascular interventional therapies. Emphasizes value in product designs that engage user interfaces and consumer behavior. Extensive knowledge of Quality System Regulations and experience with medical devices classified as Class I, II, and III, covering all stages from R&D to post-market activities.Therapy & Device Experience• Valves, stents, catheters• Cardiovascular, orthopedics• Transcatheter, minimally invasive, endoscopic, surgicalKnowledge & Technical Skills• Change leadership• Team Building & Talent Development• Organizational Management• Product Development Process optimization & phase gates• Strategy planning• Project Execution• Finance & budgeting• Design Controls• Regulations & Standards: 21 CFR, 820, QSR, ISO 13485, ISO 14971• Risk management, FMEA, failure investigation methods• Design for Reliability & Manufacturability• Device classes I, II and III
Listed skills include Medical Devices, Product Development, Cross Functional Team Leadership, R&D, and 15 others.