WORK
OBJECTIVE
Drive transformational healthcare change as a strategic, innovative, technical, and business leader in the area of medical devices, in vitro diagnostics, and biosensors.
I am driven by top teams working on revolutionary products in growing markets that will drastically improve healthcare. My goal is to strategically drive 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 medical tech environments
- Have led global, multi-disciplinary teams of over 500 associates
- Proven program/project management with 15+ 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
EXECUTIVE VICE PRESIDENT AND CHIEF TECHNOLOGY OFFICER, QUIDELORTHO: Currently EVP R&D and CTO leading a global team of 500+ associates across 4 key sites comprised of assay development, systems engineering, software engineering, regulatory, clinical, and medical/scientific affairs. Designing, developing, and launching new products in the clinical labs space (clinical chemistry and immunoassay), transfusion medicine space, and the point-of-care space (molecular and immunoassay).
Key Outputs: joined QuidelOrtho to transform the R&D organization technically and culturally with a continuous improvement mindset, new talent, and new ways of working. Pivoted the company’s molecular point-of-care strategy from an organic PCR solution to an inorganic 10-minute PCR solution involving successful M&A close, integration, and launch of LEX Diagnostics; received FDA clearance and launched the Vitros high-sensitivity Troponin I assay; received FDA clearance and launched the MTS Direct Antiglobulin Testing (DAT) Card for the Vision platform; CE marked and launched the all new Vitros 450 instrument system; and executed on numerous other product approvals and launches including software, hardware, and assays. Further, initiated multiple next-generation assay and systems projects covering the broader portfolio.
BOARD MEMBER CALIFORNIA LIFE SCIENCES: Currently serving on the board of directors of California Life Sciences (CLS) representing diagnostics (IVD) in California and helping address issues in the industry at both the state and federal levels.
CHIEF TECHNOLOGY OFFICER, CEPHEID: CTO that led and grew 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 of third-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 silicon chip based technology that enables Cepheid’s next generation multiplexed systems, and led the teams that conceived, designed, and developed Cepheid’s family of next generation / third-generation instrument systems including new, higher-multiplex capabilities, all new industrial design, and many other new features and capabilities. Further, 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
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AT A GLANCE
DEGREE
FIELDS
EXPERIENCE
Ph.D., Biomedical Engineering and
B.S., Electrical Engineering
Medical devices, in vitro diagnostics, molecular, and biosensors
Technical, business, and strategy leader with track record of driving cross-functional global teams from early stage ideation though development & validation to regulatory approval and launch
