Tarrytown, New York, United States
•20+ years IVD product development experience and extensive knowledge in Medical Device and Diagnostics •Specialize in Infectious disease and biological warfare agents •Multi-diagnostic platform experience on Roche Elecsys, Bio-Rad Bioplex 2200, DPC IMMULITE 2000 and Bayer ADVIA Centaur and CP •Managed R&D and Technical Operation Projects for IVD product management and product support •Held two U.S. patents •Over two dozen publications in book chapters and professional journals Specialties: •Infectiouse disease, immunoassay, Lean Six Sigma, PMP, IVD, DFSS •Duel major, Electrical Engineer and Biophysics Contact me: [email protected]
Accountable for IVD mmuno-based product development; Technical leadership roles to drive the project to success; Effective implementation of critical product tools, DFSS, DoE Coordiate external & internal team and decision maker; Completion of product cycle and commercialization of FDA-regulated IVD products
Experienced Scientist with proven accomplishment in Medical Device, Biotechnology, and Clinical Diagnostics; Bring in-depth knowledge in Hematology, Infectious Diseases, and immune and molecular diagnostics from R&D, Technical Operations, QC, clinical study, data management to commercialization of IVD products; Self-directed, goal driven, multi/cross functional leadership experience in management, create competitive advantages by utilizing cutting edge technical and business acumen, innovating solutions and creating positive changes through out the critical assignments in FDA regulated cGMP environment.
Consulting Services, Marketing and Sales