Vijayakumar Babu
About Vijayakumar Babu
Vijayakumar Babu is an Associate Lead Engineer at Boston Scientific with expertise in medical device validation and regulatory compliance.
Current Role at Boston Scientific
Vijayakumar Babu is currently employed as an Associate Lead Engineer at Boston Scientific in Gurugram, Haryana, India since 2020. In this role, he represents the Mechanical Team in cross-functional, product-specific meetings. He also manages critical processes such as the Change Control Board (CCB) and Engineering Change Requests (ECR), contributing significantly to project success and regulatory compliance.
Previous Experience at Tech Mahindra and PERFINT HEALTHCARE
Before joining Boston Scientific, Vijayakumar served as an Associate Team Lead at Tech Mahindra from 2018 to 2020 in Bengaluru, Karnataka, India. Prior to that, he worked as an Engineer - Mechanical at PERFINT HEALTHCARE Pvt Ltd. from 2011 to 2017 in Chennai, India. These roles allowed him to develop his technical skills and gain significant experience in mechanical engineering and team leadership.
Educational Background
Vijayakumar Babu earned a Bachelor of Technology (B.Tech.) in Mechanical Engineering from SRM University. He studied there from 2009 to 2013, equipping him with foundational knowledge and technical skills essential for his engineering career. His academic experience laid the groundwork for his expertise in various engineering and validation activities.
Validation and Quality Assurance Expertise
Vijayakumar has extensive expertise in performing validation activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for medical devices. He utilizes Minitab software for analyzing validation results in these projects. Additionally, he has knowledge in adhering to regulatory and ISO standards, including ISO 13485:2016 and US FDA’s 21 CFR 820.
Technical Proficiency in Root Cause Analysis and Audits
Vijayakumar uses Six Sigma, Statistical Process Control (SPC), and Failure Mode and Effects Analysis (FMEA) to conduct root cause analysis for non-conformance issues in manufacturing. He also supports internal and external audits and prepares technical construction files for medical devices. His activities extend to performing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for diverse equipment.