Versatile technical leader with a record of entrepreneurial success in the medical device field. Demonstrates high degree of proficiency in numerous areas applicable to product conceptualization & development, lifecycle evolution and market strategy. Due to my extensive entrepreneurial experience, I have a wide range of competencies across the entire spectrum of medical product development, but my passions lie in delivering product experiences that will delight users and improve lives.
Graphical Design and Illustration: Excellent visual presentation skills. Highly proficient in Adobe Creative Suite Products including Illustrator, Photoshop and Indesign. Professional level ability in creating photorealistic product renderings, layouts and technical illustrations for IFU documents, marketing collateral, etc. Highly proficient in organizing and visually presenting complex data sets in a clear, concise manner. Managed PowerPoint visuals and layouts for all high-profile company presentations, including presentations to the Board of Directors and strategic partners.
Early Conceptualization and Product Realization: Competitive analysis; identifying gaps and unmet user needs; generating and realizing product and process concepts to fill these needs
3D CAD Design and Modeling: Highly proficient in Solidworks 3D modeling, including advanced features such as surface modeling for curvilinear components. Knowledgeable in part design and processes for rapid prototyping, machining and high-volume injection molding
Engineering Analysis Tools: Knowledgeable in Finite Element Analysis packages including COMSOL, Solidworks Simulation and ANSYS. Also familiar with analytical and modeling scripting for Excel and MATLAB.
DirectorDec 2012 to Current Home Dialysis Plus － San Jose, CA
Led project to redesign user interface mechanisms and hardware of complex electromechanical hemodialysis machine with home use and patient-centric focus.
Led conceptualization, redesign, development and testing of high volume disposable blood tubing set.
Managed external industrial design firm, engineers, technicians and other contractors.
Drove complex cross-functional Verification and Validation effort for both capital equipment and dipsosable.
Tasks included test conceptualization, execution, protocol creation, data analysis and report creation.
Completing numerous detail-oriented deliverables to meet challenging timelines Worked closely with marketing group to ensure output from design activities satisfied user needs; participated in early device usability studies, animal studies and first-in-man.
Entrepreneur-in-residence, Senior Engineering ManagerJun 2012 to Dec 2012 The Vertical Group － Palo Alto, CA
In-house technical resource at venture capital firm developing implantable vascular access device for home hemodialysis.
Engaged and interviewed patients, clinicians and thought leaders to determine user needs and market impact of conceptualized product variants.
Performed market & competitive analysis, intellectual property analysis, concept feasibility studies and early prototyping.
Provided technical assistance to portfolio companies as needed.
Co-Founder & ManagerJun 2007 to May 2012 Spiracur Inc － CA
Advanced Design & Development Conceptualized, realized and drove core product development of innovative, patient-focused medical product that is the core technology of currently C-round Venture-funded startup Critical driver during fundraising efforts, researching and developing market models and business strategy.
Technical lead on core technology development projects, overseeing all phases of product development through Concept, Development, Verification, Validation and Transfer.
Gathered market intelligence and created models to direct company business strategy in regards to presentation of Patient and Payor value propositions Created virtually all external visual communication media for first two years of company, including product concepts, corporate identity, technical illustrations and graphics.
Interacted closely with patients and clinicians including key opinion leaders to solicit feedback regarding device performance, new features and design improvements Other tasks include: Data Analysis & automation tool development; Mechanism design & prototyping, component design, testing, sourcing and vendor management; creation & execution of Verification/Validation procedures; Design Control compliance and regulatory communication; graphical design work; Intellectual Property Development & Portfolio management.
Technical consultantSep 2007 to Dec 2008 CuraSeal － Sunnyvale, CA
Conceptualized product, developed intellectual property and assisted in fundraising for privately-funded medical device in the gastro-intestinal space.
Recently has completed First-in-man clinical experience.
Education and Training
Masters of Science, Bioengineering6 2007Stanford UniversityBioengineering
Bachelor of Science, Bioengineering6 2005University of California － San DiegoBioengineering
Participated and completed The Stanford BioDesign Innovation Program1 1
2 Issued United States Patents
45 Pending U.S. and International Patents Applications
3 Peer-reviewed Scientific Journal Articles