SH

Shannon Hoste

Sr. Director of HFE & Regulatory Strategy at Agilis Consulting Group

Shannon Hoste has extensive work experience in various roles related to human factors engineering and quality science. Shannon is currently the Vice President of HFE at Agilis by Kymanox. Previously, they worked as an Assistant Professor at Pathway for Patient Health, where they led online global courses on regulatory and legal requirements of quality, product development and validation, and risk and failure analysis. Before that, they served as the Senior Director of Development Quality and HFE at Enable Injections, Inc., and as a Product Risk Management Process specialist at Illumina. Shannon also worked at the FDA, where they held the positions of Human Factors Team Lead, Consulting Reviewer, and Standards Committee Member. In addition, they have experience as a Manager of Product Development Process at Stryker Instruments, a Design Assurance Engineer at Intel, and a Project Engineer at Battelle Memorial Institute. Throughout their career, Shannon has focused on various aspects of medical device development, including systems engineering, requirements engineering, verification engineering, risk management, design controls, and mechanical engineering.

Shannon Hoste has a Master of Science degree in Cognitive Systems Engineering from The Ohio State University. Shannon also holds a Master of Science degree in Management from Mount Vernon Nazarene University. Additionally, Shannon has a Bachelor of Science degree in Mechanical Engineering from The University of Toledo.

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