Lu Bu

Lu Bu has extensive experience in clinical engineering, serving as Manager for Clinical Engineering & Labeling and Manager of Clinical Engineering at LivaNova from 2005 to the present. Lu has led functions for new product development and strategic portfolio initiatives, overseeing design validation activities focused on usability engineering and preclinical studies. Key achievements include developing and bringing to market 12 medical devices and managing the FDA submission for Model 106 AspireSR within three months. Additionally, Lu has served as a Principal Clinical Engineer, performing risk analysis, validation testing, and generating reports for regulatory submissions that successfully obtained DEKRA and FDA approval. Lu's career also includes experience as a Clinical Quality Engineer and Research Coordinator, with educational qualifications including a BS in Biomedical Engineering from The Johns Hopkins University and an MBA in Management of Technology from the University of Houston-Clear Lake.