• Led the V&V process for a 510(k) vascular access medical device, which included designing and developing critical test protocols related to design verification and executing these protocols• Extensively familiar with operating within the confines of a quality management system to maintain regulatory compliance (ISO & FDA)• Designed and 3D-printed fixtures and mockups for design verification and packaging testing using CAD software• Managed and performed root cause investigations on any irregularities discovered with the device• Experienced with multiple roles as required at a small startup, including marketing, clinical case support, manufacturing, and quality

NoLapse (Novel Anti-Stomal Prolapse Medical Device):• Development of the first non-surgical medical device on the market to treat and prevent stomal prolapse• Clinical Manager for animal studies and human trials, developed project’s animal trial protocols• As R&D engineer, had substantial input on design of the device, including design changes due to trial data• Manager & Lead Writer on project’s NIH STTR grant; led team to exceptional impact score of 18Pectus Vac (Pectus Excavatum Medical Device):• Development of the first compliance-monitoring wireless suction device for the non-surgical treatment of pectus excavatum• Performed risk analysis, developed protocols for white-box and black-box testing• Consulted on Pectus Vac grant due to the extraordinary success of the NoLapse grant

• Production of reliable immunodiagnostic test kits for diseases such as Ebola, HIV, and Zika• Self-proficient in achieving goals required by teams further up the pipeline before deadlines• Worked with Production and R&D staff in their day-to-day activities

• Assisted patients, patients’ families, nurses, and other medical professionals• Provided assistance in hospital’s laboratory and radiology departments• Ability to effectively juggle multiple responsibilities in a quick-paced environment with no supervision