During my tenure working in an ISO13485 Medical Device development environment, I completed commercialization of several innovative design projects. These designs made it into commercial medical devices. I've received patents on several Gastrointestinal medical devices. The FDA trial I support from start to finish as a Clinical Engineer was a double blinded study with 25 centers all over the US. My role was bedside training of Physicians and staff during endoscopic implants of an intestinal stent and liner. An estimated 300 endoscopic procedures did I attend during this trial. During this time I also created databases to collect procedural, scheduling and inventory data. As a Process Engineering Technician for several years working for a Semiconductor company under ISO9001 QMS I supported a team of 20-30 employees. At times as the only shift sustaining Process Engineer. Additionally working on new process development at that time. Below are some additional skills acquired along the way:●Software: CAD/ Solidworks, MS Office Professional, Oracle, Agile, VAX/ PROMIS Database●Physician Training: Large Clinical Trial - Animal Training and Clinical Use of Device (Bedside Instruction on Advanced Endoscopic and Fluoroscopic Procedures). Large and Small Groups.●Design Engineering: Conceptualize, Design (using Solidworks), and Prototype - Endoscopic Based Non-Invasive Medical Devices. ●R&D Project Management: Implantable and disposable Gastrointestinal Medical Devices●Vendor Credentials: Reptrax, VCS, Vendor Mate, Parallon and Medstar●Achieving several patents some still pending: Duodenal Anchoring Concepts and Endoscopic Gastrointestinal Procedures etc.