Sai Akhil Kumar y

Mechanical Test and Validation Engineer @Thermo Fisher Scientific

millersburg, PA, US

At Thermo Fisher Scientific, I executed advanced mechanical characterization and structural validation of catheter-based medical systems under ISO ISO 13485, and 21 CFR 820 compliance frameworks. Responsibilities encompassed the design, development, and qualification of tensile, burst, flexural, and fatigue test methodologies using Instron and MTS servo-hydraulic load frames to quantify device performance under physiological stress states. Applied finite strain theory, Prony series viscoelastic modeling, and constitutive parameter derivation to characterize non-linear polymeric deformation and predict fatigue life. Authored and implemented IQ/OQ/PQ protocols, ensuring traceable calibration of load cells and extensometers in accordance with ISO/IEC 17025. Integrated Critical-to-Quality (CTQ) linkage matrices within the validation framework to maintain alignment with ISO 14971 risk management principles.

University of Bridgeport

Master's degree