At Medtronic, I support medical-device design and development under Design Controls, ISO 13485, and FDA requirements. I develop mechanical components and assemblies in SolidWorks, and plan and execute characterization and Design Verification testing.
At Preceptis Medical, I performed testing of medical-device materials, components, prototypes, and finished products, and supported Design History Files, risk management, and regulatory documentation. I also worked with customers and manufacturing teams to address technical concerns and develop practical engineering solutions.
Earlier, I supported computerized system validation and quality work in pharmaceutical manufacturing at Divis Laboratories, Adrta Technologies Private Limited, and Sri Krishna Pharmaceuticals. My work included validation documentation and testing, equipment qualification, deviation investigations, and quality records in regulated environments.
