Abdul Ajith Email & Phone Number

As a Senior Engineer at Tata Elxsi, I apply my strong knowledge and skills in medical device design and development process and quality management process to ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820.30 and 820.198 standards. I have successfully completed multiple projects involving design verification and validation, risk assessment, complaint handling, and corrective and preventive actions for post-market medical devices.Prior to joining Tata Elxsi, I worked as a Regulatory Affairs Specialist and a Lead Engineer at HCL Technologies, where I gained valuable experience in medical device regulatory submissions, quality audits, and design control activities. I also enhanced my proficiency in Creo, Solidworks tools that enables me to create and modify complex 3D models and drawings. I hold a B.tech degree in Mechanical Engineering from Hindustan University Chennai, where I developed my problem-solving, analytical, and technical skills. My goal is to leverage my education and experience to contribute to the innovation and quality of medical device design and development.