John A. Steen, Ph.D., President
John has spent nearly his entire career in the medical device industry. After receiving a Bachelor’s degree from Brown University and a Master’s degree from New York University in Aeronautical Engineering, John worked briefly in the aerospace industry before completing his Doctorate in Biomedical Engineering at New York University. He then worked as a biomedical engineer in the standards division of the U.S. FDA, focusing on anesthesia, cardiovascular, and respiratory care products. In 1982, John went into private industry with Sheridan Catheter Corp., where he worked as Technical Director, Vice-President of Manufacturing, and later Vice-President of Research and Development. John joined CRI in 1991 as Vice-President of Product Development and Operations, and became President and CEO shortly thereafter. John became an owner of the company in 2004 with two partners, and in 2005 took on a new role as President, with a focus on new product evaluation and development. On Nov 1, 2006, he purchased CRI from his two partners and now owns 70% shares.
Christine Cook, General Manager
Christine joined CRI in 2005 as Director of Operations, bringing with her 20 years of manufacturing operations, materials and quality assurance experience in the medical device industry. Before joining CRI, Christine served as Director of Manufacturing and Director of Materials at Gibeck-Dryden and King Systems Corporation in Indianapolis, Indiana. Most recently she was a Product Development and Product Life Cycle Manager at Trivirix International, a medical electronics design and manufacturing firm. At Trivirix, Christine had a significant role in quality assurance and regulatory compliance, as well as new product design project management. Her extensive experience within the medical device industry includes participation in countless FDA, ISO Registrar, supplier and customer audits. These extensive audit participations results in a strong foundation at CRI for continuous improvement and streamlined Quality Management systems. Christine has a Bachelor’s degree in Business Administration and Business Management.
Gary T. Cerasale, Vice President Operations
Gary comes to CRI with nearly 30 years of aerospace, electronic component, medical device & industrial equipment manufacturing experience. His extensive background includes Lean manufacturing, Six Sigma quality techniques, and manufacturing engineering, as well as proven leadership skills and a commitment to team building, problem solving, and process improvement. While working for Bendix Corporation and Allison Gas Turbine (Div. of GM), he was heavily involved with the development and implementation of cellular & FMS manufacturing systems and was very instrumental with new system and equipment start-ups. In his previous position as Director of Quality for Peerless Pump, Gary was responsible for implementing an ISO-certified quality system across multiple plant locations, and completed a successful initiative to obtain CE marking for various products. He also established the company's Six Sigma program. As General Manager for Peerless Pump, he was responsible for test facilities and manufacturing systems upgrade programs that improved quality and increased production throughput. Gary has a Master’s Degree in Manufacturing Management from GMI Engineering & Management Institute and a Bachelor of Science degree in Industrial Technology & Industrial Arts from Central Connecticut State College. He also has Six Sigma Champion and Black Belt certificates from the American Society for Quality (ASQ); a Diploma in General Management from Ashridge Management College (Berkhamstead, England); and Lean and Plant-Site Leadership certificates from the University of Tennessee.
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Kashif Qasim, Financial Controller
Financial and Information Systems Controls are Kashif’s main areas of responsibility. He also manages Employee Stock Ownership Program (ESOP) for CRI. Kashif joined Catheter Research with more than 13 years of diversified experience in fields of Finance and Information Technology at various levels from consulting to senior management. He started his career as an accountant in 1996 with BOC Group, UK that specializes in producing medical devices. Kashif advanced his career by managing several SAP implementation projects worldwide. Later he worked with a consulting firm where he managed several projects in IT infrastructure, IS applications, Oracle Siebel CRM, and Change Management; from conceptualization to deployment. He also held various senior positions in finance and is experienced with maintaining and managing accounting, finance, and treasury operations. He has helped organizations in business acquisitions and systems integrations. He is a Certified Management Accountant(CMA) and VMWare Certified Professional (VCP). He holds a Bachelor Degree in Commerce. He holds several certificates of merit for special education.
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Babacar Diouf, Director of Regulatory Affairs and Quality Systems
A native of Senegal, Babacar speaks four languages to go along with his degree in Geological Engineering from The Institute of Earth Sciences (IST) of Cheikh Anta Diop University of Dakar, Senegal. Before moving to the United States, Babacar worked in the mining industry in Africa as a field geologist with AngloGold Ashanti with his main focus in geochemical exploration. Before joining CRI in early 2005 as a quality engineer, he spent four years in quality assurance with Autoliv ASP, a leader in automotive safety products. Babacar has received additional training in ISO13485:2003, FDA QSR 21 CFR 820, European MDD, Canadian-MDR, Risk Management, Sterilization of health care products and Contamination Monitoring - Environmental Control. Babacar is a certified ISO13485:2003 auditor, an ASQ Certified Quality Auditor, and an ASQ Certified Quality Engineer. Babacar is a member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professionals Society (RAPS).
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Betelehem Hamde, Materials Manager
A native of Eritrea, Beth immigrated to the United States in 1995. Working her way up through the organization, Beth has held several key positions at CRI. Hard work is her mantra. Starting on the production floor in 1998, she demonstrated her ability to stick to task and complete large volumes of work with high quality. In 1999, she was promoted to receptionist and administrative specialist. During this time, Beth began assisting in the material planning and purchasing department. By 2002, Beth was in charge of production scheduling, material and MRO procurement and inventory control. In 2006, she was promoted to Materials Manager, responsible for vendor compliance with ISO13485:2003 and FDA QSR 21 CFR Part 820. Beth completed her Associates degree at the University of Gondor Medical Science in Ethiopia, majoring in Anatomy and Biology. Beth is a member of the American Production and Inventory Control Society, (APICS) working towards her CPIM certification.
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Carolyn Dowd, Accounting and HR Manager
Carolyn came to CRI with 18 years of experience in administrative, financial and human resources management in the medical device manufacturing industry. Her experience includes manufacturing cost accounting, financial statement preparation, cash flow analysis, and audit and tax compliance, along with extensive acquisition due diligence. Carolyn has a Bachelor of Science degree in Accounting from the University of Indianapolis.
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Suzy Sundling, Quality Manager
Suzy received her Bachelor’s degree in Biomedical Engineering from Rose-Hulman Institute of Technology in 2007. Upon graduation, Suzy began working for Boston Scientific as a Process Engineer, working extensively in validating and optimizing their extrusion lines. Suzy joined CRI in August 2008 as a Biomedical Engineer. Her experience with Boston Scientific brings specialized skills to CRI in performing effective Installation, Operational, and Performance Qualifications in accordance with industry requirements and provides additional depth to CRI’s engineering department. In January of 2010, Suzy was promoted to Quality Manager due to her excellence performance in engineering and project management.
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Chris Ross, Mechanical Engineer
Chris joined CRI in 2002. He has earned his Bachelor of Science degree in Mechanical Engineering Technology from Purdue University. During his college years, he participated in a two year co-op with Union Carbide Corporation in their battery division. This blend of on-the-job experience while earning his degree strengthened his skills in Mechanical Engineering concepts and intensified his learning experience at Purdue. Following graduation, Chris accepted a position with Onkyo America. He traveled to their corporate facility in Japan to learn about work cell optimization. He responsibilities included fixture design, technical troubleshooting, new product introduction and new equipment specification and installation. Chris now supports CRI in all of these roles, including design and development for medical devices. His strong background and experience has resulted in excellence in mechanical engineering concepts.
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Wahid Kapadia, Manufacturing Engineer
Wahid brought 15 years of diversified experience to CRI in lean manufacturing, process improvement, quality engineering, and production supervision. He started his career as design engineer at Rolls-Royce (Allison Gas Turbine) in their test department where he was responsible for jet engine test cells upgrades and modifications. Prior to joining CRI, Wahid was a new models process development engineer at Ford Motor Company. In this role, he was heavily involved with the development of new processes for manufacturing precision power components. During his tenure at Ford Motor Company, he gained an in-depth understanding of flexible work cells, equipment installation and qualification, lean process initiatives, control plans, FMEA and project management. This experience enables CRI to continue moving forward into lean manufacturing to provide an even higher level of service to our customers. Wahid has a BS in Mechanical Engineering from Purdue University and is a Six Sigma Black Belt.
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Nathan D. Glass, Biomedical Engineer
Nathan began his career in 2001 as a Pharmacy Technician, compounding patient-specific medications in a highly regulated inpatient hospital setting in Indianapolis. He also chaired the Department of Pharmacy Technology for National College in Indianapolis. Nathan received his Bachelor of Science degree in Biomedical Engineering from Indiana University – Purdue University at Indianapolis with a minor in chemistry. While pursuing his engineering degree, he also studied computer aided design and economic theory. Nathan joined CRI in 2009 as a Biomedical Engineer; he assists in product development and design, biomaterials research and sourcing, and is also involved in the design of product manufacturing processes and process improvements.
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Jane N. Nguyen, Biomedical Engineer
Jane received her Bachelor of Science degree in Biomedical Engineering from Texas A&M University with minors in Electrical Engineering and Mathematics. While pursuing her degree, Jane worked with the Space Engineering Institute working on an autonomous robot cooperative system, a joint project with Texas A&M and NASA. She was part of a co-op program with The Texas Heart Institute in Houston and worked with the College of Veterinary Medicine at Texas A&M supporting pathologists in the analysis of cardiovascular pathology in various biomedical devices. As a member of the engineering team, Jane helps drive development projects for catheter applications.
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