Nr Koka

Founded and built MedDeviceAudit, an AI-powered SaaS compliance auditing platform for Class II medical devices, implementing IEC 62304, FDA QMSR 2026, ISO 13485:2016, and ISO 14971 requirements. Architected the platform's 9P/2G Evidence Engine with SHA-256 evidence anchors to evaluate design artifacts against regulatory intent.

Supported products throughout all development phases, test protocol development, and process qualification/validation for Impella heart pumps and AIC software. Participated in risk management and worked as Quality Lead on Impella Connect platform (SaMD) using Azure cloud.

Reviewed MDD technical files, identified compliance gaps, and performed mitigation for MDR submissions. Developed and managed Design Control processes compliant with FDA QSR, EU-MDR, and ISO 13485.

Ensured QMS artifacts related to the Design History File were generated at the right level of detail. Reviewed design verification and validation, created traceability, participated in design reviews, and worked as Quality Lead on Elsevier app (SaMD) using Azure cloud.

Managed and coordinated design and development of complex Class II and Class III medical devices. Generated and maintained project plans, task lists, and risk registers, and coordinated activities across functional groups.

Joined Eye Surgical Project team to execute strategic objectives and complete projects. Worked on secured eyeTELLIGENCE application (SaMD) on IBM Cloud, and developed planning documents, engineering studies, and design verification for product enhancements.

Ensured compliance to design change procedures and global regulations, and directed all phases of Complaint/CAPA projects. Collaborated to ensure safety and availability of remote cardiac monitoring devices, reducing complaint rates.

Worked with project team through end-to-end development lifecycle for a social website using agile methodology. Participated in estimating, planning, and management, and supervised offshore team.

Provided support to two dialysis products (Claria and Vivia) across multiple business functions. Served as Quality Lead for Sharesource Cloud Infrastructure Project (SaMD) and data migration, and supported post-market surveillance reviews.

Managed offshore team of 2 QA testers, testing full lifecycle for a $25M project. Wrote and reviewed test cases and documents, oversaw functional and regression testing, and developed 'SCT in the Cloud' project using Windows Azure.

Oversaw data validation processes for applications and technology within Invasive Cardiology Division. Orchestrated software reliability planning, execution, and tracking, and formulated verification plans and traceability matrices.

Oversaw software, systems, and service engineering under Transfusion Therapeutics Division. Managed 22 onshore and offshore staff, drove successful testing and implementation of 4 software releases, and streamlined approval process.

Master of Science in Electrical and Computer Engineering from the University of Iowa.

Bachelor of Engineering in Electronics and Communication Engineering from Osmania University.