Steve Shane

Background

About Steve Shane

I’m the guy who fixes things. Whether it’s solving complex product development challenges, rescuing failing client relationships, or leading teams through high-stakes initiatives, I find a way to make things work. I’m a value creator who builds and leads high-performing teams, driving innovation in healthcare by creating practical solutions that deliver real results. With a proven track record of overcoming challenges in the medical device industry, I’m known for stepping into difficult situations and finding a path to success. I thrive in environments where things aren’t working, and I bring a hands-on, problem-solving approach to every challenge—whether it’s turning around a multi-million dollar project, fixing technical issues under tight deadlines, or guiding teams through complex organizational changes. My focus is always on getting things done, empowering teams to take ownership, and delivering results that matter. Specialties: Product development history across medical devices, diagnostics, and drug delivery products. Practical expertise in general management, P&L, VOC, systems engineering, risk management, process design, process validation, product validation, analytics, lean process design, 6-sigma methodologies, team building, project management, program management, portfolio management, and business process architecture. Experience leading world-wide teams with collaborations in India, Europe, Central America, and South America.