Vincent Yeh Email and Phone Number

➢ Led the redesign of the Nellix™ Console – implemented improved manufacturing processes and eliminated redundant features, resulting in a 50% cost reduction.➢ Responsible for drafting component and assembly CAD files and technical drawings using SolidWorks and writing Quality System documentation, including manufacturing instructions and quality procedures.➢ Delivered device training, demonstrations, and presentations to educate physicians and new team members.➢ Responsible for Design Control documentation including translating physician input into design specifications and writing design qualification, verification, and validation protocols/reports.➢ Led a cross-functional team through the design and development activities to successfully launch the AFX™ Introducer System, resulting in $7M in revenue with over 25,000 units sold worldwide.➢ Partnered with Regulatory Affairs to drive an on time Premarket Notification (510(k)) submission.➢ Directed and supervised vendor activities for critical components, ensuring inventory and establishing new supply chains.➢ Performed device testing and evaluation throughout the product development life cycle to verify and qualify device performance.

Device Design· Worked on designing, developing, and enhancing several iterations of annuloplasty ring prototypes for the treatment of heart valve disease.· Created animations, presentations and figures as well as 2D and 3D drawings of concept products as part of new patent applications.Device Testing· Wrote, implemented, and executed bench device testing protocols to evaluate existing products and future generation prototypes. Including device and equipment validation testing, functional testing, and packaging testing.· Collected and analyzed test data with the use of technical equipment and devices, such as LVDT, thermocouple, Smart Scope, Chattalion, and force gauge.· Actively participated and contributed in the operating room during animal studies.Quality System Maintenance· Responsible for maintenance of GMP systems, production of 3D CAD files and technical drawings with SolidWorks and quality assurance procedures for document control.· Worked closely with manufacturing engineers in the transfer of R&D design to manufacturing through the development of manufacturing protocols.

· Involved in design and testing of heart valve delivery system prototypes· Assisted the engineering team in problem solving and improving key system components· Responsible for writing SOP and MP for newly developed system components

Studied cardiac gene development and function in Zebrafish.