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Bill Braden has over 19 years of experience in manufacturing, with a wide range of disciplines, including research and development through transfer to manufacturing of Class I, II, and III medical product. He has experience with client relations, regulatory audits; including FDA, and being able to manage multiple project, while performing complex tasks, achieving schedule, and quality objectives. While at HEI, Integrated Cable Systems, E-M-Solutions/Sanmina-SCI, K-Tect Electronics, and Toshiba International Corp he worked with suppliers to address all issues of start-up, served as a lead to all new product review to include project breakdown, assigning tasks to other departments, created client presentations & proposal, worked with customers to define test requirements, design, and implementation of test methods, as well as designed tooling and test fixtures. (Automated and manual.)
Bill’s educational background is in Electrical Engineering, but with a Six Sigma Black Belt and 5 years of experience in the United State Army, including “Advanced Individual Training” and “Primary Leadership Development Corse” he demonstrate the confidence and experience needed to complete any project.
Bill has over 30 years of experience in engineering, operations, manufacturing & program management of medical, industrial, and instrumentation products. While Bill’s formal training is in mechanical engineering he has extensive management experience directing engineering and regulatory teams in the development and manufacturing of complex diagnostic devices. Bill has either contract or direct product development and manufacturing experience with companies such as Datex Ohmeda, HEI, Denver Instrument, Sartorius, J&J, Biosense Webster, St. Jude, GE Healthcare, and CardioOptics.
Bill has a Bachelor of Science in Mechanical Engineering from the University of Colorado at Boulder.
Jon VonOhlsen, a Chief Technology Officer, cofounded Quest Product Development Corporation in January 1995. Jon is a Senior Electronic Engineer, Project Manager, and Principal Investigator at Quest.
While at Quest Jon has been involved in the analytical instrumentation industry, with the last several years emphasizing medical instrument design and development. He has been responsible for design, development, V&V, transfer to manufacturing, and project management for 4 medical devices; the most complex of these systems was an immunoassay system with throughput of 300/hour. He also leads the design effort on direct patient contact devices for cardiac treatment and compliance with safety standards like UL 60601-1, a fully electronically endoscope, and the research, development, & fabrication of thin-film electronics and controlled actuators at Quest.
Lindsay has over 30 years of experience with product development program management and engineering. He has extensive experience defining process, managing, and participating in development of multiple-technology medical devices and software applications. In these roles, Lindsay has worked with diverse organizations including medical device developers and manufacturers, aerospace companies, and small businesses such as property managers and retailers in direct, outsource, and independent consulting roles. Lindsay has managed projects for companies including Bayer, Biomerieux, Bausch and Lomb, Abbott, ConMed, and a number of startups. With a degree in electrical engineering, Lindsay spent several years designing electronic circuits and systems, and eventually expanded into program management, compliant process development, and system engineering.
His primary role as a Project Manager includes project planning, risk analysis, scope management, team building, subcontractor management, requirements and regulatory compliance process definition, schedule, and budget. His strengths lie in building collaborative relationships among management, marketing, and engineering groups to realize innovative solutions. Lindsay has been involved in the development of more than 40 products. Approximately 30 were in the medical device field and 20 have FDA market clearances. He also holds a patent for an automatic closed tube sampler.
Lindsay holds a Bachelor of Science in Electrical Engineering from the University of Colorado, and is a registered Professional Engineer in the state of Colorado.
Scott is a Mechanical Engineer and Project Manager with 20 years of experience using Pro/ENGINEER and SolidWorks. He has extensive experience in research and development of biotech and analytical instruments as well as fluidics systems. His design strengths include motor/drive mechanisms, molded parts, design for manufacturability, and enclosures.
Mr. Dye has a Bachelor of Science in Mechanical Engineering from the University of Colorado at Denver.
Tim Holzschuh joined Quest Product Development Corporation in April 2007. Between then and June 2009, when he became a Project Director, he played a major role as a member of the Quest Electrical Engineering team.
Tim has worked on numerous medical devices, including pneumatic tonometers, lithotripsy pulse power generators, dynamic foot compression devices, electrocautery surgical device fixturing, ionic therapy generators, and validation of EEG peripherals.
Tim’s instrument and commercial product experience includes pH meters, centrifuges, high speed switch mode power conversion, battery chargers & analyzers, G-force meters, and thermal barcode printers.