- Authored / Reviewed Technical Documentation for submission of a Class III medical device • Authored non-clinical portions of TD • Reviewed all sections of TD and formatted final TD for submission to notified body • Write timely responses to requests after TD submission- Author / Review FDA (EFS, IDE, PMA), EU, and Health Canada regulatory submissions and assessments for existing clinical and commercial Class III medical devices- Develop and implement regulatory strategies and processes for sustaining and NPD projects- Directly communicate with regulatory agencies to align on submission and response strategies and support agency audits- Evaluate proposed changes to product design and manufacturing processes and assess their impact to clinical and commercial projects and to existing regulatory strategies- Review and approve NPD and product modification documentation- Work cross-functionally throughout the development, launch, and commercial processes

- Supported PASCAL program clinical design freeze through commercialization, including designing, testing, and implementing product and manufacturing updates- Sustained PASCAL R&D activities after EU commercialization, including: • Supporting product transfers to Ireland and Singapore • Ongoing supplier activities to support Global Supply Chain second sourcing efforts • Complaints handling and root cause investigation • Biocompatibility assessments for post-commercialization changes- Partnered with regulatory affairs to respond to regulatory body queries in a concise and timely manner to successfully meet approval timelines- Participated in organization and execution of Design Verification (DV) testing including System DV, corrosion, GLP chronic animal studies, and biocompatibility testing- Managed inventory and supported documentation efforts to successfully implement an Edwards production site transfer for PASCAL commercialization- Worked on design and feasibility testing of next generation concepts and prototypes, including managing animal studies and participating in new test method development- Mentored and guided other engineers on PASCAL and other Edwards processes- Presented PASCAL technology at other Edwards manufacturing sites in preparation for future transfer activities- Presented PASCAL Implant background to onboard new PASCAL engineering and cross-functional team members- Used aseptic technique to prepare sterile devices in support of clinical trial cases - Managed vendor relations and procured components for DV and biocompatibility testing- Created Intellectual Property (IP) for next generation concepts of PASCAL product line- Completed training workshops on leveraging diversity, risk management, CREO, Nitinol fundamentals and processing, and Nitinol FEA and fatigue testing, and more- Attended conferences to enhance knowledge of heart disease and existing technologies in the cardiovascular space

- Managed a project to modularize the cleaning process and increase cleaning capacity for Advanced Technology implant and delivery system components- Collaborated with microbiology, biology, and chemistry SMEs to prove the efficacy of the new cleaning equipment/system- Authored and executed numerous IQs to qualify existing and new equipment- Wrote set-up and use procedures for new automated salt bath for Advanced Technology shape-setting processes- Worked with process development SMEs to improve the IQ Protocol template for more efficient, streamlined use- Proficient in Ignite Teamcenter and experienced with Change Requests and Simplified workflows

- Generated a funding proposal and negotiated a 44% increase in annual budget - Liaison to ASME competition committee, sponsors, vendors, and other resources - Organize and maintain scheduling and execution of all events (e.g. PDR, CDR, etc.) - Interpret and ensure adherence to rules and procedures of competition - Supervise and guide four team members to maintain overall project structure

- Tutor college students in mathematics, effectively raising passing rates for entire classes and individual students- Grade assignments and proctor exams for over 40 students at a given time

- Researched the effect of orientation on properties of an EVA/polyurea bilayer - Developed COMSOL FEA simulation to model bilayer behavior under compression - Created DOE and prepared samples for testing in Dynamic Mechanical Analyzer

- Executed 9 IQs and 2 OQ/PQs to complete a major cleanroom line move - Characterized and validated a weld procedure and wrote an OQ/PQ for attaching cable to platinum contacts for spinal cord leads in high volume production - Investigated, evaluated, and implemented CAPAs - Participated in creating FMEA for new spinal cord lead processes - Streamlined the calibration procedure for 22 resistance welders based on each welder’s range of use for its specific process - Reviewed Q2 change requests and appropriately revised all associated documents - Completed training for over 65 regulations and procedures

- Successfully persuaded new schools to enroll in the enrichment program - Supervised, trained, and maintained schedules for multiple coaches - Communicated with parents, teachers, and school administrators to encourage program participation and facilitate classes