September 11, 2007 – 11:26 pm
Chief Technology Officer, Kai Sensors, Honolulu, HI, 2008-present
Developing a radar-based non-contact monitoring device that measures respiration rate and patterns for vital signs spot checks and long-term monitoring, with applications in the home, kiosk, and hospital.
- Identified workflows and prepared timelines and budgets for new products, during R&D, product development, regulatory, clinical, and manufacturing phases.
- Implemented Quality System complying with 21CFR part 820 and ISO 13485: developed quality system procedures, selected and customized electronic document control system compliant with 21CFR part 11, and managed Design Control documentation for company’s first product.
- Prepared 510(k) submission for company’s first product. Submission was approved in 4 months.
- Performed market research and led risk assessment; used this information to prepare User Needs and System Requirements for company’s first product.
- Led business development and demonstration meetings with potential customers and presented product information in fundraising meetings.
- Devised product enhancements and prepared provisional patent filings for these inventions.
Staff Engineer, Drug Device R&D, ALZA Corporation, A Johnson and Johnson Company, Mountain View, CA, 2006-2007
Developed electrical current controllers for clinical and preclinical studies of iontophoretic drug delivery and studied feasibility of integration of sensors with drug-delivery systems.
- Discovered trend in clinical study data and used it to develop a patentable algorithm for next-generation IONSYS product (patent application in process).
- Proposed patient-safety enhancements for IONSYS product to R&D, medical, and marketing teams by highlighting best candidates following review of technology and assessment of compatibility with IONSYS value proposition.
- Wrote technical specifications and request for quotation, and led selection of contractor for design and development of new Phase I clinical study device.
- Selected and managed 3rd party vendors to build and repair pre-clinical testing devices and to generate required design control documentation.
Research Assistant (PhD Thesis), Stanford Transducers Lab, Stanford University, Stanford, CA, 2001-2006
Developed a system based on a single-chip radar for non-contact, through-clothing measurement of heart and respiration rates, including iterative architecture and system design and human subject studies.
- Improved radar system SNR by identifying limiting factors and improvements; proved the analysis was correct through laboratory experiments and human subjects studies.
- Led effort to obtain approval for Human Subjects Protocol from NASA and Stanford institutional review boards and performed method comparison study on 22 human subjects.
- Developed MATLAB software to separate superimposed heart and respiration motion signatures and determine rates from motion signatures as well as from gold standards.
- Designed and executed the first published experimental verification of range correlation theory.
- Determined the location and amount of skin surface motion due to heartbeat, pulse, and respiration by reviewing and evaluating medical and engineering literature.
Senior Technical Associate, Bell Laboratories, Lucent Technologies, Murray Hill, NJ, Summers 2000 & 2001
- Solved phase-demodulation null point problem by implementing quadrature receiver and appropriate signal processing in 2.4-GHz CMOS direct-conversion radar.
- Laid out integrated circuit, designed printed circuit board, and performed testing for the first fully integrated silicon CMOS single-chip Doppler radar transceiver.
RF Hardware Engineering Intern , Dynamic Telecommunications, Inc., Germantown, MD, Summer 1999
- Enabled high-performance radio product launch by redesigning the frequency synthesizer to reduce phase noise.
Systems Engineering Intern, Raytheon Electronics Systems, Portsmouth, RI , Summer 1998
- Developed a relational database for submarine sonar system with a team of engineers.
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