- Train and support physicians for the FDA EndoBarrier Clinical Trial

- Trained 100+ physicians with both a didactic and practical program, led them through the first set of implants, and provided support through all subsequent cases - Selected and developed Centers of Excellence for numerous European and Middle Eastern Countries- Worked closely with the engineering team to ensure physician feedback and design recommendations were communicated clearly and implemented - Worked closely with the marketing team to help direct focused campaigns in specific markets- Strong understanding of clinical, regulatory and local healthcare requirements that helped lead to reimbursement in specific countries

- Project Manager of the company’s sole commercial product- Designed and engineered various new product prototypes using bench testing and SolidWorks.- Managed development of animal models for new product efficacy and safety testing- Updated and implemented new physician training program - Analyzed and reported on clinical data needed to support design changes

- Developed test methods, work instructions, validation protocols and reports for initial human clinical builds- Preformed process FMEA, process validation, and other risk management activities- Initiated and reviewed Document Change Orders for product and process related changes- Designed and built numerous fixtures to increase production quality and output using SolidWorks- Ran numerous IQ, OQ and PQ on new tooling and equipment