Expert Details

Expert in Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control

Expert ID: 734985 California, USA

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Expert possesses a 30-plus-year track record managing medical device and in-vitro diagnostics development from concept to successful market introduction. A proven manager, he has accrued significant skills in leading diverse and multi-organizational teams in the successful development of leading edge, products with innovative new features.

Embedded real-time systems ~ Digital signal processing ~ Electrochemical Biosensor systems~ Microfluidics ~ Software/hardware architectures ~ User interface design ~ Optics and electro-optics ~ Image processing algorithms ~ Laser technology ~ Endoscopy ~ Ultrasound imaging

Expert possesses extensive experience managing software development. He has also accrued lengthy experience in FDA Quality Systems, Design Control and ISO 9001/13485 regulations for product development.

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Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control

Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California - San Diego, California - Long Beach, California - Santa Ana, California - Anaheim, California - Riverside, California - Glendale, California - Huntington Beach, California - San Bernardino, California - Chula Vista, California

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Education

Year Degree Subject Institution
Year: 2000 Degree: Ph.D Subject: Physical Chemistry Institution: University of California
Year: 2000 Degree: BS Subject: Chemistry Institution: University of Wisconsin

Work History

Years Employer Title Department Responsibilities
Years: 2008 to Present Employer: Undisclosed Title: Engineering Consultant Department: Responsibilities: Expert has consulted independently from 2008 to present. He has also worked as an Engineering Consultant from 2001 to 2004 and from 1985 to 1988. As an Engineering Consultant, Expert has undertaken the following projects:

POC instrument platform for nucleic acid diagnostics
Automated PCR-based clinical chemistry device blood bank application
Benchtop automated clinical chemistry diagnostic instruments.
Microfluidic based DNA and pathogen screening instruments.
High throughput automated clinical chemistry diagnostic instrument.
High throughput automated immunoassay instrument.
Handheld spectroscopic clinical instruments for immunoassays and pathogen detection.
Desktop Optical rt-PCR DNA detection instrument.
Productization of special purpose DNA synthesizer for production

In consultative roles in prior decades, Expert conducted the evaluation of contract engineering firms to develop a genomic diagnostic instrument; served as Technical Director for a project to develop a handheld tonometer; designed optics and wrote software for an embedded bar-code reader; and designed control compliance evaluation.
Years: 2004 to 2008 Employer: Osmetech Molecular Diagnistics Title: Vice President Department: Systems Development Responsibilities: Expert assembled a team consisting of in-house engineers and scientists along with multiple outside contract firms. He and his team developed a DNA detection platform after obtaining FDA 510(k) clearance and earned several awards as a result.
Years: 1997 to 2001 Employer: Micro Medical Devices, Inc. Title: Vice President Department: R&D Responsibilities: Expert established engineering and operations infrastructure and the QSR system for this startup medical device company. He also managed OEM suppliers. Products: micro endoscopes for minimally invasive orthopedic surgery, real-time endoscope image processing systems, functional endoscopic imaging, and a surgical station prototype.
Years: 1992 to 1996 Employer: Mentor Ophthalmic. Inc. Title: Director of Advanced Development Department: Responsibilities: Expert organized and staffed a firmware and digital design engineering group. He also created and implemented the first FDA compliant Design Control system. Products developed: Ultrasound imaging instrument, handheld biometer, pachymeter and tonometer.
Years: 1988 to 1991 Employer: Nihon Kohden America, Inc. Title: Director of Product Research Department: Responsibilities: Expert was responsible for technology assessment, clinical research support and software development.
Products Developed: Remote EKG telemedicine software.
Years: 1982 to 1985 Employer: Coopervision, Inc. Title: Director of Engineering Department: Diagnostic Imaging Division Responsibilities: Expert created and staffed a new engineering department for newly created division. Products Developed: Ultrasound imaging instrument, pachymeter, biometer, laser surgery device.

Fields of Expertise

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