Highly skilled and proven
Executive team
Scott Ludecker
President & Chief Executive Officer
President & Chief Executive Officer
With more than 25 years of experience in the global medical device industry, Scott is a proven industry leader with a demonstrated track record of successfully commercializing disruptive medical technology. Developing new markets and the teams to deliver above industry growth rates is his passion. Scott has extensive experience with both start-up and turn around companies having generated in excess of $1.2 billion in shareholder value through strategic exits. He is a graduate of Kenyon College.
Stacy Miller
Sr Vice President Human Resources and Operations
Sr Vice President Human Resources and Operations
Spanning a career of more than 20 years, Stacy has served in senior human resources leadership positions developing, overseeing, and managing policies and programs for high growth companies; both private and public. Her experience includes global talent management, recruiting, corporate compliance, rapidly expanding organization staffing, mergers and acquisitions, and operations. She is a graduate of Virginia Tech.
Management team
Mark Melkerson
Senior Regulatory Lead
Senior Regulatory Lead
Mark’s impressive 33-year career with the US Food and Drug Administration (FDA) included the positions of Deputy Director, Office of Health Technology 6 – Orthopedic Devices where he oversaw the pre-market and post-market regulation of orthopedic medical devices as well as Director, Division of Orthopedic devices, Division of Surgical Devices, and Director of General Restorative and Neurological Devices where he oversaw pre-market regulation of those medical device areas. His vast experience includes Medical Devices, Bio-mechanics, Biotechnology, U.S. Food and Drug Administration (FDA), and Research and Development (R&D). Mark is a strong business development professional with a Master’s and Bachelor’s Degrees focused in Mechanical Engineering with Biomedical Thesis and Biomedical Option respectively from Michigan State University.
Peter Bayer, PE, MSME
Senior Engineering Lead
Senior Engineering Lead
Peter comes to BlueOcean with over 32 years of project management and engineering experience in medical product development. He held key product and business development roles at Medtronic and Orchid Orthopedic Solutions and has run many successful product development projects, leading cross-functional teams involving clinical, marketing, regulatory, quality and manufacturing resources. His projects have included devices and systems for laparoscopic surgery, orthopedics (including spine, extremities, sports medicine, and trauma), diagnostics, women's healthcare, and cardiac surgery. He is named on 32 domestic and international patents with additional patents pending.
Fred Fiore
Senior Quality Management Lead
Senior Quality Management Lead
Fred Fiore possesses a BS in Business Management as well as a certification as an FDA/ISO Lead Quality Auditor through BSI and SAI Global, two of the world’s leading ISO certifying agencies. His background, experience and credentials encompass over 40 years of Quality Assurance Management for the Medical Device, Aerospace, Laboratory, Commercial and Food Industries.
He has spent 30 years in the arena of Medical Device manufacturing, the most recent of which was in the blood, tissue and stem cell industry, working with both large and small companies successfully developing, managing and guiding them through cGMP / GLP / GTP, FDA / QSR, ISO 9001 / 17025 / 13485 / MDD and MDSAP requirements.