Over 15 years of experience in developing medium and large-scale software/hardware systems for biomedical research, clinical medical devices, materials analysis, semiconductor, and telecommunication industries. ·Proficient in FDA Regulations (21 CFR Parts 11 and 820), ISO Standards, PMI PMBOK, CMM and RUP processes. ·Experienced in development and execution of feasibility studies and clinical trials in the US and in Europe. ·Years of experience in management of multi disciplinary project teams, simultaneous projects, multiple locations. ·Strong strategic planning, technical assessment, staff management, leadership and communication skills used for motivating and guiding development teams from initial product specifications through release. ·Competent programmer and designer, utilizing formal software/hardware engineering principles in the development of high quality, low defect software/hardware products. ·Full Product Development Life Cycle Experience including software and hardware development. Specialties: measurement systems, medical imaging, clinical studies, molecular imaging, software development, near infrared (NIR), long wave infrared (LWIR), algorithm development, project management, program management