2011 CONFERENCE SPEAKERS

Steve Fening Stephen D. Fening, Ph.D.
Director, Orthopaedic Devices
Medical Device Development Center
Austen BioInnovation Institute in Akron

Dr. Fening serves the director of orthopedic devices within the Medical Device Development Center at ABIA. In this role, Fening drives innovation in orthopaedic device development within ABIA and its partners. He previously served as the director of sports health research at Cleveland Clinic, where he had a joint appointment in the departments of orthopedic surgery and biomedical engineering. Fening has undergraduate and masters degrees in mechanical engineering, a doctorate in biomedical engineering, and a postdoctoral fellowship in orthopaedic biomechanics at Cleveland Clinic. His areas of research focus are on cartilage injury modeling and biomechanics of the knee and shoulder. Fening was awarded the Cleveland Clinic Innovator Award in 2008, as well as the "Basic Science Teacher of the Year" by the department of orthopedic surgery, and a distinguished educator by The Cleveland Clinic.

  John A. Freije CQE, CMfgT
President/Principal Consultant
Freije Quality Engineering, LLC
(American Society for Quality- Biomedical Division)

John Freije spearheads Freije Quality Engineering's quality system support services. In this capacity he works with medical device companies and suppliers to develop and implement quality systems that exceed the expectation of ISO 13485 and FDA's Quality System Regulation 21 CFR 820.

Freije has over 28 years experience working for the government as well as the private sector, with 17 years in the medical device and pharmaceutical industry. Experience includes over five years supporting internal and external quality systems and various product lines at Roche Diagnostics as a quality systems principal, 1.5 years as a product assurance manager for Raytheon Technical Services Company supporting projects for the special forces and direct fire control, over 12 years in various engineering and quality positions at Eli Lilly and Company supporting bulk manufacturing for injectables and dry products manufacturing for clinical trials, medical device commercialization and manufacturing, as well as serving eight years in the Ordnance Corps in the US Army as a systems mechanic.

Bill Garcia William Garcia
Managing Partner
TableForce, LLC

Bill Garcia is a contract negotiator, negotiation trainer and worldwide motivational speaker. Garcia's corporate career experience includes direct sales and sales management, export sales to Latin America, national sale and account management, and vice president of sales and marketing positions. His entrepreneurial experience includes being a founder and board member of a business-to-business global sourcing company, as well as several other smaller LLP ventures. Garcia has demonstrated experience in idea generation, capital raising, business development, executive level team building and execution.

Garcia & Associates began as counsel to various Fortune 100 companies during contract negotiations in 1997. He and his partners regularly sit at-the-table representing both buyers and sellers. Additionally his organization provides customized negotiation training worldwide (over 35 countries on 6 continents).

Garcia holds a masters of international management from "Thunderbird", and received his bachelor of arts from the James Madison College of Michigan State University in international relations. He's also completed the Kellogg School of Management, University of Notre Dame and Harvard Law School programs in negotiation strategies.

Bill Garcia Andrew Miclot
Senior Vice President, General Manager
ArthroCare ENT

Andrew has over 25 years of executive management experience within the medical device industry and is currently the senior vice president and general manager of ArthroCare ENT. He was president and CEO of Ascension Orthopedics prior to ArthroCare. He also held senior level positions at Orthofix, Symmetry, J&J Depuy and Zimmer among others. During his 13 years at Symmetry, where he held several positions including senior vice president and investor relations officer, he played a meaningful role in growing Symmetry's annual revenue from $10 million to more than $260 million and with Symmetry's initial public offering on the New York Stock Exchange.

  Stan Revers
Manager, Business Development
Performance Review Institute (Nadcap)

Stan Revers has been involved with many facets of program research and development, working with Performance Review Institute (PRI) since 2007. In this function, Revers has been responsible for the identification and development of new programs and business opportunities as well as the establishment and support of global partnerships and international business relationships. His role required the research and analysis of business opportunities to motivate and guide industry managed committee activities in the effective and efficient development of new programs, as well as the strategic expansion of existing PRI programs for the satisfaction of industry needs.

Revers has successfully managed the daily program development activities of eQuaLified at PRI from its initial conception through full service realization and global program launch. He has also served as staff engineer for the Nadcap Electronics Task Group (ETG), leading the industry-managed development of technical checklists and requirement documents for aerospace manufacturing process control audits. During this assignment, the ETG realized significant growth in Nadcap audits. His other responsibilities have included the effective supervision of assigned personnel, including support staff, consultants, technical contractors, etc, as well as the preparation and management of budget considerations in support of industry-managed program and corporate goals.

Stan holds a bachelor of sciences in chemical engineering from Carnegie Mellon University in Pittsburgh, Pennsylvania, USA. He is a member of the Society of Automotive Engineers (SAE), American Society of Training & Development (ASTD), American Institute of Chemical Engineers (AIChE) and is active within the mobility industry's professional development sector.

Schafer Shawn E. Schafer
Vice President, Sales and Market Development
Oberg Medical

Shawn E. Schafer has served as the vice president of sales and market development for Oberg Medical (Pittsburgh, Pennsylvania) since July of 2008. Prior to that, Mr. Schafer has served in various senior management roles within Oberg including positions in sales, marketing and program management. Mr. Schafer brings over 20 years of precision contract manufacturing experience from the medical device and other relevant industries. Mr. Schafer is a 1991 graduate of The Indiana University of Pennsylvania with a Bachelor of Sciences degree in Marketing.

Bill Garcia Richard A. Vincins, CQA, RAC(US, EU)
Vice President Quality Assurance
Emergo Group

Richard A. Vincins is part of the Emergo Group as vice president of quality assurance, responsible for quality assurance and regulatory affairs activities. In this role he is responsible for the implementation of quality systems, conducting internal audits, training on quality system tools, and providing regulatory expertise in national and international regulations. He brings more than 20 years of experience in the medical industry including worldwide regulatory compliance efforts for medical device, IVD, and pharmaceutical companies. His work experience at companies like Medtronic and bioMerieux include establishing quality systems to ISO standards, 510(k) submissions, and CE marking of multiple product lines. Vincins is an ASQ certified quality auditor and holds a regulatory affairs certification for United States regulations and European Union regulations through the Regulatory Affairs Professional Society. Richard graduated from Bridgewater State College, MA, with a bachelor's degree in biomedical biology.

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