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
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
|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 Employer from 2001 to 2004 and from 1985 to 1988. As an Employer, 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
acoustic imaging, endoscopy, endoscope, laser, image processing hardware, image processor, image processing, electrooptics, electrooptic device, optical system design, optics, user interface, computer user interface design, graphic user interface design, computer peripheral device, software architecture, electrochemical sensor, electrochemical system, digital signage, digital signal processing, digital signal, real-time embedded system software development, embedded system software development, design management, budgetary control, project management, clinical laboratory, clinical laboratory equipment, instrument design, instrument development, software system development, Food and Drug Administration, in vitro diagnostics Food and Drug Administration code, in vitro diagnostics, medical device, medical device design, leadership, technology innovation, management, innovation