As Senior Technical Program Lead at FDA, I led two major enterprise initiatives that transformed the agency's data infrastructure and supply chain management capabilities:CDRH Enterprise Data Hub (CEDh):Led the development of FDA's enterprise-level AI-ready data warehouse, transforming legacy systems into modern cloud-based solutions. Key achievements:• Architected and implemented enterprise data infrastructure that reduced processing time by 80% while maintaining FISMA high compliance.• Designed scalable data engineering pipelines for 20+ datasets using medallion architecture.• Transformed program strategy from DaaS into a comprehensive PaaS solution for teams within FDA. • Modernized data governance using cutting-edge AI technology to democratize data access.Resilient Supply Chain Program (RSCP):Spearheaded the development of an innovative program to prevent medical device shortages using AI and advanced analytics. Key achievements:• Built program from inception, developing core vision and engineering strategy.• Delivered scalable cloud infrastructure in 6 months, enabling ML/NLP models for shortage prediction• Engineered data pipelines integrating 13 internal/external datasets in FISMA high environment• Scaled team from 2 to 20+ engineers across multiple work streams.• Established comprehensive program management framework including SOPs, work instructions, and management plans.

• Led the modernization and data integration efforts of VA Enterprise Architecture Repository (VEAR) and VA's System Inventory (VASI).• Managed Database Tools, Dashboard and Web/Communication Agile teams as team lead and scrum master. • Core member of the team that helped develop strategic direction and FY22 goals for Enterprise Architecture (EA) under EASS contract. • Initiated development of a new data flow to optimize the datasets used by VA EA dashboards.• Proposed and lead development of a new role-based access data intake process to modernize the current process and tool. The tool was designed as a single source for data intake, data visualization and data reporting to replace three different tools being used, to aid towards the mission of good stewardship.

• Supervised activities of the dashboard team and staff under Architecture and Engineering Services (AES). • Streamlined the VA enterprise architecture (EA) dashboards by standardizing the reports, centralizing the datasets to reduce redundancy, optimizing the most used reports, reducing the total reports using widgets, added video trainings and increased awareness of the data that improved the monthly usage of the reports by 2 times. • Developed SMART performance goals for the dashboard team and provided updates to the government leadership monthly. • Conducted update and maintenance of the standard operating procedures and supporting documentation for the team. • Extensive experienced in agile project management and ceremonies, like daily scrum, user stories planning, refinements and retrospectives.

• Core member of a cross functional team that provided strategic direction, data modeling, data cleaning and statistical analysis to one of the largest clinical trials in diabetes industry collecting over 9 million data points, 60k reference measurements. • Managed a team of data scientist and analyst in development of data visualization dashboards to provide valuable insights to senior management on roadmap progression and earnings call. • Managed data analytics and visualizations methods to improve the data quality, by implementing checks at different steps and software validation and verification per the SOP’s. • Mentored and coached my team in successful publication of the real-world data using Analytics Data Manager (ADM) in reputable peer reviewed journal. • Developed a crash course to coach and train the technical workforce under engineering and other departments at Senseonics.

• Managed data science and analytics team in development of Analytics Data Manager (ADM) that helped analyze commercial user’s real time data to drive business intelligence and reimbursement claim support that helped in insuring 11-16 million covered lives. • Developed algorithms to improve the accuracy and usability of our next generation continuous glucose monitoring (CGM) sensor and reduce daily required calibrations by 50%. • Served as a technical expert in customer care and sustaining engineering department.• Revamped the data monitoring and visualization tools to increase the efficiency of the clinical database managers. • Developed visualization dashboards to provide real time review of the clinical data for monitoring purpose.

• Developed algorithm for automatically detecting electronic failures of the sensors and alerting the subjects for safety and effectiveness of our glucose monitoring system. • Developed physiological feedback-based noise filtering algorithm to improve accuracy of the CGM system. • Developed software testing protocols of CGM glucose algorithms, equivalence and performance update of our embedded software. • Led team of engineers in design, development and V&V testing of a data acquisition and statistical analysis software tool in C#/MATLAB through the software life cycle towards the FDA/CE approval of our CGM. • Experienced in monitoring of clinical sites and generating patient compliance reports that lead to successful completion and submission of our CE and FDA pivotal study. • Experienced in data analysis generating reports and plots about the clinical findings, to both scientific advisory board and executive board members. • Worked in a cross-function team in the review and design of the clinical site instructions, eCRF forms and software tools for upcoming clinical studies. • Working knowledge of good clinical practices, ISO-14155 and ISO-13485.

• Centralized the entire clinical and sensor QC data and developed software solution to query the data, which reduced the old manual process by 90%. • Applied six sigma techniques to resolve design issues of the clinical data acquisition tool and sensor parameters estimation tool to reduce the processing time by 80%. • Conducted parameter sensitivity analysis to make the real time continuous glucose monitoring more robust and accurate. • Independently developed the core technology for analyzing data from the automated testing and calibration station (ATCS) and conducted system testing to make it ready for use at production and in house by research scientists. • Developed and tested algorithms for analyzing the sensor QC parameters to provide in depth summary about the individual sensors. • Experience performing validation and verification testing of continuous glucose monitoring setup.

• Developed the core technology of an improved automated "intutive" zooming computer algorithm and image simplification tool to improve performance while accessing visual line diagrams using haptic display devices • Experience designing and conducting extensive user based clinical experiments and user surveys. • Designed and developed a software tool for providing access to overlapping information and a calibration tool, using tactile and auditory feedback for individuals who are deaf-blind or visually impaired. • Developed several fun and interactive haptic display gaming tools for varying age groups ranging from children to adults. • Experience writing proposals and presenting work to both engineering and non-engineering audiences.

• Engineered and tested a sensor based auto correction system for compensating angular rotational errors of VT Player when used by blind individuals. • Developed an improved position concordant haptic display device for individuals who are blind or visually impaired and conducted clinical experiment for testing the performance improvements. • Developed prototype of a haptic (vibro-tactile) blood glucometer for individuals who are deaf and blind.• Mentored undergraduate students research projects.

• Experience providing technical support, both over desk and phone.• Repaired laptops, performed OMR scanning and students grade reporting. • Worked as a computer lab assistant helping students with technical issues in the computers labs.