Results-oriented Senior Engineer/Senior Scientist with more than 10 years of hands on experience in engineering, biomedical and optical technologies in academia, clinical trials, and medical device industry. Self-motivated with ability to handle several projects while managing others in an R&D setting. Proven track record of meeting deadlines and budget. Well developed communication skills. Principal author in 8 peer reviewed manuscripts, with16 total.Specialties: • Development of FDA approved Class II device• Manufacturing Process Development• Root Cause Analysis, CAPA, FMEA• Verification and Validation • Analytical and numerical modeling• Fluorescence & Reflectance Spectroscopy • Managing technical teams• Clinical data acquisition & statistical analysis• Liaison between engineers and physicians• ISO 13485 and cGMP regulations• Laser-Tissue Interactions, Biomedical Optics• Study Design, DOE• FDA submissions, IDE & 510(k)
Listed skills include Medical Devices, Biomedical Engineering, Fda, R&D, and 31 others.