I am a dedicated professional with a passion for developing innovative medical devices that make a real difference. My goal is to continue pushing the boundaries of technical textiles (particularly the rapidly evolving field of e-textiles) in healthcare technology, ensuring that every product I work on is both groundbreaking and dependable.Experience:- Lead product development activities for wearable breast cancer screening devices, contributing to the ideation and realization of new product development i.e., a reusable self-use breast cancer screening patch, designed for privacy and ease of use.- Expertise in rigorous quality inspections, guiding product enhancements, identifying areas for improvement, root cause analysis, and CAPA implementation to enhance product quality.- Spearheaded the documentation process for ISO 13485 certification, ensuring compliance with international standards for medical devices.”- Played a pivotal role in the preparation and submission of documentation for CDSCO: MDR 2017 certification, collaborating with cross-functional teams to ensure thoroughness and accuracy.- Supported internal and external audits, providing detailed reports. Meticulous documentation for all phases of product development, QC/QA, and regulatory processes.