Pradeesh Vinothkumar
About Pradeesh Vinothkumar
Pradeesh Vinothkumar is a Senior Engineer at QuEST Global in Bangalore with over 8 years of experience in the medical domain, specializing in Shelf Life Aging studies, DHF Remediation, and 510K submission projects.
Current Position at QuEST Global
Pradeesh Vinothkumar currently holds the position of Senior Engineer at QuEST Global. He is based in Bangalore Urban, Karnataka, India. In his role, he utilizes his extensive experience in the medical domain to contribute to the company's engineering projects.
Previous Experience at HCL Technologies
Before joining QuEST Global, Pradeesh worked at HCL Technologies. He held the position of Lead Engineer from 2017 to 2021 in Chennai, Tamil Nadu, India. Prior to that, he was a Test Engineer for three years from 2014 to 2017. His responsibilities during his tenure included conducting Shelf Life Aging studies and DHF Remediation on ISO standards.
Educational Background
Pradeesh Vinothkumar completed his education at Mahendra Institute of Engineering and Technology. He attained a Bachelor of Engineering (BE) degree in Mechanical Engineering, studying from 2009 to 2013. His academic background laid the foundation for his subsequent expertise in engineering, particularly in the medical field.
Proficiency in Medical Device Engineering
With over 8 years of experience in the medical domain, Pradeesh is proficient in conducting both real-time and accelerated Shelf Life Aging studies. He has worked on several 510K submission projects and has a strong command of Test Method Validation. His skills include writing technical documents such as Design Verification Plans, Protocols, and Reports.
Expertise in ISO Standards and Regulatory Compliance
Pradeesh has strong exposure to multiple ISO standards including ISO 13485, ISO 17025, ISO 14971, ISO 11608-1, ISO 11608-2, ISO 8537, and ISO 7864. He led DHF Gap Assessment and Remediation projects in compliance with MDR regulations. His expertise also spans Risk Management, Failure Investigation Analysis, and CAPA investigation.