Eugene Wu, D.V.M., Ph.D.                                                               

Sr. Quality Engineer

More than 10 years experience in cardiovascular / pulmonary clinical and pre-clinical research.   More than 20 years experience in animal studies including animal models, in vivo research, animal health care, and surgery.   More than 10 years experience in hardware and software development and testing.  

EXPERIENCE ...

• Clinical studies: Activities included 1) formal presentation (knowledge review, study design, center training, study progress update, and study results), 2) document writing and review (proposal, project plan / functional plan, clinical study protocol, investigational guideline, CRFs, study report, and manuscript), 3) studies coordinating and execution (communicating with FDA, managing study centers, and supervise study procedures), and 4) data analysis.  
• Responsible for test method validation protocols development, system validation, and verification test protocols development, tests execution, and reports writing for endovascular catheters, device delivery systems, and medical devices (e.g., drug-eluting stents).   Apply six-sigma concept to identify non-compliant issues and develop problem solving strategies / plans.
• Research fields include CHF CRT therapy, atrial fibrillation therapy, and hypertension therapy Extensive experience in the areas of:
• Biomaterials surface modification and chemical analysis
• Biocompatibility & histocompatibility
• Medical device design and evaluation (cardiovascular catheter, vascular graft, vascular stent)
• In-vivo testing of implants
• Electromechanical instrumentation development
• Test method development and validation
• Developed a minimum invasive physiological data monitoring system
• Designed silicone prosthesis, which prevents post right pneumonectomy syndrome.
• Evaluated and enhanced a non-invasive medical device which measures cardiac output and pulmonary diffusing capacity.
• Developed and executed software/hardware test plans and test cases as well as performance of verification and validation phases.
• Supervised graduate students in experimental surgery as well as the design and fabrication of medical devices including catheters, vascular stents, heart valves, intraocular lenses.
• Designed a non-invasive medical device that provided real time monitoring for continuous recording of oxygen consumption and ventilation.
• Coordinated multidisciplinary projects, which were collaborated between research facilities and biomedical companies.

POSITIONS HELD...

• Senior Quality Engineer                                                           BioTeknica
• Principle Scientist                                                                    Guidant CRM
• Systems Verification Engineer, Hardware/Software             Alcatel
• Software Engineer                                                                  Nortel
• Assistant Professor                                                                Univ. of Texas

EDUCATION...

• M.S. Software Engineering                                                     University of Texas
• Ph.D. Biomedical Engineering                                                  Clemson University
• Doctorate Veterinary Medicine                                               National Taiwan University