• Implemented customer experience program for 4 franchises by creating KPI’s that affect the customer, starting a Net Promotor Score program, and identifying key accounts for focused feedback• Interviewed customers, led market research studies, quantified customer needs, and worked with internal stakeholders to drive change, increasing the Net Promotor Score by 5 points• Conducted monthly status update meetings with division leadership to track division performance and project timelines• Coordinated vendor selection and contract review and submission• Participated in department annual strategy planning, driving the development of team objectives• Developed and validated Power BI dashboards for quality metrics, saving 30 engineering hours monthly• Led health hazard evaluation, field action, and CAPA project to correct product nonconformance in the field and internal processes to prevent recurrences• Design Assurance Cross-Training: Design assurance core team lead, including authoring risk management and V&V planning documents and managing DHF for design change project

• Identified need for continuous improvement and implemented process change in product investigation process to improve investigation traceability and decrease investigation time by 8%• Investigated 5000+ product complaints, identified root causes, and documented the results• Identified trends within post-market data for escalation and additional action• Developed software test cases for new product development verification testing and performed requirement tracing• Supported complaint IMDRF coding switch to align with new EUMDR coding requirements• Supported internal and external site audits, both in back room and front room• Reviewed calibration work orders

• Supported instrument and simulator-based software integration and verification efforts and worked directly with software developers to resolve product technical issues identified during agile development• Developed test cases for software design verification testing

• Authored design verification/validation protocols & reports and performed design verification testing for CardioMEMS Heart Failure Sensor• Analyzed data using Minitab to evaluate the equivalence of testing at multiple sites following manufacturing transfer• Validated test methods by performing Gage R&R studies• Supported design control remediation efforts in preparation for upcoming FDA audit• Led design change review meeting for CardioMEMS Heart Failure sensor and delivery system

• Analyzed the effects of attribute and continuous process variables to identify cause of bimodal data and ran process qualifications to ensure a stable and capable process• Reverse engineered competitor samples to develop prototypes for customer• Collaborated with multidisciplinary bioscience team and customers to develop innovative solutions to satisfy customer needs