Expert in Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control
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.
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
|Year: 2000||Degree: Ph.D||Subject: Physical Chemistry||Institution: University of California|
|Year: 2000||Degree: BS||Subject: Chemistry||Institution: University of Wisconsin|
|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.|