About the Contributors
Brian Biersach is the founder of and senior biomedical engineer for Medical Equipment Compliance Associates, LLC., which handles the evaluation and testing of medical equipment to the IEC/UL/CSA/EN 60601-1 and other medical standards. He holds a BS degree in biomedical engineering from the Milwaukee School of Engineering, and a BA degree in economics from the University of Wisconsin-Madison. Brian is also a U.S. expert for AAMI on IEC/ISO Working Groups for international medical standards writing committees. Prior to founding MECA, Brian worked for Underwriters Laboratories, Inc. (UL), as a medical device reviewer and project engineer, a primary instructor for UL’s medical seminars and workshops, and an accredited FDA 510(k) reviewer, under the Food and Drug Administration Third Party Review Program.
Timothy Cathcart is consultant and owner of ISQ Systems in Rhode Island. He has been involved in military systems engineering for many years.
Jeff Geisler has 25 years of experience in embedded software development with firms large and small. Trained as an analytical chemist, he decided early in his career that he would rather build instruments than tend them. He joined a start-up as a scientist, and then moved into developing the software for their laser-based spectroscope used to measure respiratory gases and inhaled agents during anesthesia. He then joined the leading firm in portable medical x-ray fluoroscopy as a software team leader. Currently he is software architect at another start-up, developing the software for a next-generation blood pump that assists the pumping action of native hearts in patients with congestive heart failure.
Jeff has lectured at multiple conferences on software development for medical devices, approaches to safety critical software, and software testing. He lives in Salt Lake City, Utah, with his wife. His current non-work enthusiasm is smart phone software development.
Chris Hersman works at the Johns Hopkins University/Applied Physics Laboratory (JHU/APL) and is currently the mission system engineer for NASA’s New Horizons mission to Pluto. Since the mission proposal in 2001, he has been responsible for the spacecraft system engineering. After the successful launch of New Horizons in January 2006, his role was expanded to include other mission-related technical responsibilities. He also serves as assistant chief engineer of the Space Department at JHU/APL.
After receiving an MS in electrical engineering from the Ohio State University, Chris began his career in the space industry in 1990 at JHU/APL. Over the past 19 years he has worked on a number of Earth-orbiting and interplanetary missions, including the Midcourse Space Experiment, TIMED, OrbView-3, and Near Earth Asteroid Rendezvous, as well as New Horizons.
Jeremi Peck is the Vice President and senior biomedical engineer of Medical Equipment Compliance Associates, LLC (MECA), which provides medical companies with certification and regulatory compliance services. He holds a BS degree in biomedical engineering. Prior to working for MECA, Jeremi was a medical device services engineer and reviewer for Underwriters Laboratories, Inc. (UL). He was an instructor for UL’s medical seminars and workshops, an accredited FDA 510(k) reviewer under the FDA Third Party Review Program, a technical expert for healthcare electrical systems per NFPA 70 and NFPA 99, and a technical expert for the European Medical Device Directive (for CE marking).
Jeffrey M. Sieracki is an “extremely applied mathematician” with over 25 years experience in computer-based systems engineering for industry, Department of Defense, and academia. He holds degrees in physics and applied mathematics from Johns Hopkins University, and a doctorate in applied mathematics and scientific computing from the University of Maryland. He presently directs SR2 Group, LLC., a private R&D firm with which he has worked on diverse applications, including medical devices, optical electronics, pollution control, RADAR, acoustics, terrain mapping, and signal and image processing. Prior to the SR2 Group, Sieracki co-founded Stimsoft, Inc., a medical device company focused on neural stimulation for pain control. Prior to Stimsoft, he consulted for industry and university clients on numerous projects in both mission-critical, real-time systems, and scientific computing. Sieracki holds or has pending 15 U.S. patents, has published in journals, including the Proceedings of the National Academy of Science, and maintains an adjunct appointment with the University of Maryland as a visiting research scientist.
David Tyler is Vice President of Advanced Automation Corporation in Rome, New York. He has been involved in military systems engineering for many years.