October 23, 2009 – 11:44 pm
Chief Technology Officer, Kai Sensors, Honolulu, HI, 2008-present
Developing a portfolio of radar-based non-contact respiratory measurement and monitoring devices that operate through clothing and bedding. Leading development of the company’s first product, which is the first FDA-cleared respiratory rate spot check device and the first FDA-cleared Doppler-radar-based physiological monitoring device, intended to provide an automated alternative to visually counting breaths to obtain respiratory rate. One of three officers developing company strategy and product roadmap, including generating budgets and timelines and positioning company within the market.
- Led and directed team of 5 software, RF, and digital hardware engineers to take a respiratory monitoring prototype to an FDA-cleared, manufacturable product
- Prepared 804-page FDA 510(k) submission for company’s first product; responded promptly to FDA feedback; obtained clearance 4 months after submission
- Wrote specification and claims for patent covering company’s core technology and products
- Designed clinical studies in support of FDA submissions and marketing goals; analyzed clinical study data and prepared related reports and publications
- Determined positioning strengths for company’s technology platform, used these strengths to shape product strategy, and developed marketing materials to convey these strengths
- Designed focus groups and interviewed physicians to determine new product requirements
- Identified and summarized relevant medical research and generated marketing documents citing research to support business development efforts
- Led business development meetings with potential customers and prepared demonstrations of technology for these meetings; presented product information in fundraising meetings
- Implemented Quality System complying with 21CFR part 820 and ISO 13485: developed quality system procedures, selected and implemented electronic document control system compliant with 21CFR part 11, managed Design Control documentation for company’s first product
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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