WORK
OBJECTIVE
Drive transformational healthcare change as a strategic, innovative, and technical leader in the area of medical devices, in vitro diagnostics, and biosensors.
I am driven by top teams working on revolutionary products that will drastically improve healthcare. My goal is to strategically drive & technically manage innovative initiatives that change the game for patients and providers alike. I work for patients.
TECHNICAL PROFILE
- Strong interdisciplinary engineering and biomedical background
- Extensive experience with systems, devices, and technology integration
- Design, prototyping, and large scale manufacture of medical devices
- Hardware and software development for instrumentation support
- Assay development including surface chemistries and signal transduction
PERSONAL PROFILE
- Proven leadership in cross-functional R&D and Ops environments
- Have led global, multi-disciplinary teams of over 150+ associates
- Proven program/project management with 10+ IVD product launches
- Natural leader with excellent communication and management skills
- Persistent and creative problem solver
- Excels in challenging environments
EDUCATION
- Ph.D., Biomedical Engineering
- University of California, Irvine
- M.S., Biomedical Engineering
- University of California, Irvine
- B.S., Electrical Engineering w/Biomedical Engineering Option
- University of California, Los Angeles
EXPERIENCE HIGHLIGHTS
CHIEF TECHNOLOGY OFFICER, CEPHEID: CTO leading and growing a group of 150+ global associates comprised of Cepheid’s dedicated early-stage Technology & Innovation Team as well as a dedicated Product Development unit focused on development and launch f next-generation multiplex molecular diagnostics systems, software, consumables, and assays.
Key Outputs: supported key aspects of Cepheid’s growth and products during COVID, led the successful M&A close and integration of a pre-revenue company with technology that enables Cepheid’s next generation systems, and drove and supported key open/external innovation initiatives for alternate molecular diagnostic platforms and technologies, at both the Cepheid and Danaher levels
VICE PRESIDENT TECHNOLOGY & INNOVATION, CEPHEID: Grew and led Cepheid’s global innovation team of scientists, engineers, and tech scouts to drive organic and open-innovation projects focused on assay, chemistry, systems, and consumables to lay the foundation of Cepheid’s next-generation capabilities for the GeneXpert system and assays
Key Outputs: established a “light and fast” innovation idea/project framework to prioritize and drive projects, initiated multiple external partnership projects (incl. driving Danaher-backed start-up investments) to advance detection capabilities of the GeneXpert, drove innovation of host-response based assays, re-ignited Cepheid’s instrument/system development efforts with multiple next-gen systems, and contributed to multiple diligence, M&A, and strategic planning efforts for Cepheid and Danaher
SR. DIRECTOR ENGINEERING, CEPHEID: Special assignment reporting to Cepheid’s CEO/President leading large and cross-functional development teams focused on new iterations of GeneXpert systems
Key Outputs: moved the GeneXpert Omni platform, including assay hardware, assay, software, and manufacturing aspects, through the Technical Feasibility phase including the first real-world field studies in South Africa, led the engineering grant writing initiatives that resulted in a multi-tens of millions of dollars contract from the US government to help accelerate GeneXpert system and consumable technologies, and initiated and launched (CE-IVD) the new GeneXpert Edge system for TB & HIV diagnostics
DIRECTOR ENGINEERING PROGRAMS, CEPHEID: Director of the Engineering Consumables R&D Group & technical program director of the Cepheid-USPS-Northrop Grumman Biohazard Detection System (BDS) partnership
Key Outputs: established the Engineering Consumables R&D group, led the R&D group to design a new injection-molded GeneXpert cartridge component for high-multiplexing & demonstrated PCR proof-of-concept, and addressed BDS program business continuity concerns to maintain the program’s multi-million dollar yearly revenue stream
PROGRAM MANAGER, CEPHEID: Product development program/project manager across all areas at Cepheid, including hardware/instrument systems, software, and assays/cartridges
Key Outputs: 10+ IVD product launches including worldwide launch of the GX Infinity-80 instrument the Xpert CT/NG assay
CO-FOUNDER & LEAD ENGINEER, IGLYKO, INC. FOR GLUCOSE SENSING: Worked in the business, financial, and technical arms of the company for the development of a fluorescence-based continuous glucose-sensing intravenous catheter
Key Outputs: developed hydrogel chemistries, fabricated fiber-optic systems, and established proof-of-concept in whole blood
SKILLS OVERVIEW
STRATEGY: strategic planning, landscape assessments, ROIC models, voice-of-customer, and numerous framework tools
INNOVATION: innovation process incl. Technology Readiness Levels, portfolio management, and early-stage investments
LEADERSHIP: global and multi-disciplinary team building and leadership, situational leadership, $50M+ budget responsibility
MANUFACTURING: multi-cavity injection molding incl. overmolding, lyophilization, high-throughput assembly and automation, IOPQ, process validation, and QC/failure investigation
FABRICATION: CNC prototyping, injection-molding, bonding, surface treatments, MEMS/photolithography/cleanrooms
BIO/CHEMICAL: DNA/RNA assays (amplification reactions), immunoassays, surface immobilization, gel/matrix chemistries
SYSTEMS: electrical, optical (fiber-optics, LEDs, PMTs), thermal (thermoelectrics, thermal modeling), magnetics
SOFTWARE: CAD (SolidWorks, Pro/E, AutoCAD), CAM (Pro/E), LabVIEW, Microsoft Project, Minitab, Windows, Mac
PUBLICATIONS: 30+ conferences and papers including numerous 1st authorships
IVD STANDARDS: ISO 13485 (CE-IVD, IVDD and IVDR), ISO 14971, QSR 21 CFR 820, Risk Mgmt/FMEA, Tech File, 510(k)
SELECT WORK EXPERIENCE
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PUBLICATIONS
CLICK HERE TO VIEW FULL JOURNAL PUBLICATIONS LIST ON LEGACY SITE
CLICK HERE TO VIEW FULL CONFERENCE PUBLICATIONS LIST ON LEGACY SITE
CLICK HERE TO VIEW FULL LIST OF OTHER PUBLICATIONS LIST ON LEGACY SITE
AT A GLANCE
DEGREE
FIELDS
EXPERIENCE
Ph.D., Biomedical Engineering and
B.S., Electrical Engineering
Medical devices, in vitro diagnostics, molecular, and biosensors
Technical and strategy leader with track record of driving cross-functional teams, large and small, from early stage ideation though development & validation to regulatory approval and launch
