B Jeslin A R Alex

About B Jeslin A R Alex

As a Lead Engineer specializing in medical device design, I am committed to advancing…

Experience

1. Lead Engineer

   HCLTech

   Aug 2022 — Present · Chennai, IN

   I specialize in establishing and maintaining Quality Management System (QMS) frameworks aligned with ISO 13485 standards. This involves implementing robust design controls, overseeing CAPA (Corrective and Preventive Actions), and managing supplier quality management processes to ensure operational excellence. At the forefront of innovation, I lead the design and development of cutting-edge medical devices, meticulously ensuring compliance with regulatory standards such as ISO 13485, ISO 14971, EU MDR 2017/745, and FDA guidelines. Collaborating closely with regulatory affairs teams, I navigate the comprehensive approval process for medical devices, ensuring adherence to rigorous marking standards and regulatory requirements. My role encompasses conducting thorough risk assessments, hazard analyses, and validation testing to guarantee compliance with regulatory standards. I manage regulatory submissions and approvals for medical devices, collaborating with regulatory affairs teams to meet marking requirements and ensure market readiness. With a focus on quality assurance, I establish and implement processes and procedures to verify and validate medical device designs, including rigorous design verification testing (DVT). Additionally, I evaluate new materials, components, and technologies for potential integration into medical device designs, always mindful of regulatory considerations.

Education

• Central Institute of Plastics Engineering & Technology (CIPET)

  Master of Technology - MTech

  2017 — 2019

• Anna University

  Bachelor of Engineering - BE

  2011 — 2015