Brian De Santis
About Brian De Santis
Brian De Santis is a Principal Engineer at Mammoth Biosciences, specializing in firmware development for RNA/DNA molecular diagnostic systems using CRISPR technology. He has a background in software engineering across several companies, including Terumo Cardiovascular Systems and Autoliv, and holds a BSEE in Electrical Engineering from Lawrence Technological University.
Work at Mammoth Biosciences
Brian De Santis has been serving as a Principal Engineer at Mammoth Biosciences since 2022. His role involves leveraging his extensive experience in firmware development for molecular diagnostic systems that utilize CRISPR technology. He is based in Brisbane, California, where he contributes to the advancement of innovative diagnostic solutions.
Previous Experience at Terumo Cardiovascular Systems
Prior to his current position, Brian worked at Terumo Cardiovascular Systems from 2008 to 2012 as the Chief Software Engineer in the R&D department. During his four years there, he focused on developing software solutions tailored for cardiovascular medical devices, enhancing his expertise in the medical technology field.
Career Background in Software Engineering
Brian's career includes significant roles in various companies. He served as a Senior Software Engineer at Autoliv for nine months in 2012-2013 and worked at Robert Bosch as a Senior Software Engineer from 2003 to 2008. His diverse experience in software engineering has equipped him with a robust skill set in developing software for medical and automotive applications.
Education and Expertise
Brian earned a Bachelor of Science in Electrical Engineering (BSEE) from Lawrence Technological University, where he studied from 1990 to 1995. His educational background laid the foundation for his extensive knowledge in software quality design and regulatory compliance, particularly in the context of medical devices.
Regulatory Compliance and Standards Knowledge
Brian has worked closely with FDA auditors to ensure that software quality systems meet regulatory standards. He specializes in software quality design and has established processes that comply with IEC guidelines for class 2 and class 3 medical devices. His knowledge encompasses IEC 62304, ISO 26262, ISO 14971, and 21 CFR 820 standards.