Bharathi Vinoth M

About Bharathi Vinoth M

Experienced Mechanical Engineer with a proven track record in the medical device industry, currently contributing at HCLTech in ensuring compliance with EU MDR 2017 standards through robust engineering change management and product lifecycle processes. I have actively supported DHF remediation, eBOM/mBOM structuring, and advanced product data management using Siemens Teamcenter Unified to streamline design and process updates for regulatory-critical medical devices.Certified in SolidWorks and PTC Creo, I bring strong CAD and CAM capabilities, complemented by hands-on expertise in PLM (Teamcenter), Lean Manufacturing, APQP, and PPAP. My role also encompasses comprehensive risk management (FMEA) and the development of accurate, compliant product technical documentation. I am deeply involved in new product development (NPD) initiatives, ensuring cross-functional collaboration, traceability, and quality throughout the product lifecycle.Dedicated to delivering high-quality, regulatory-aligned engineering solutions that enhance product innovation, traceability, and market readiness.

Experience

1. Software Engineer

   HCLTech

   Jan 2024 — Present · Madurai, IN

   Regulated client medical devices for compliance with EU/MDR 2017 standards, focusing on quality aspects.•Worked extensively on Engineering Change Management (ECM) and Product Data Management using Siemens Teamcenter Unified (TcU).•Drafted and maintained essential medical device documents, including DHF Remediation, manufacturing documentation, and other regulatory requirements.•Created and managed eBOM and mBOM based on client specifications, supporting design and process changes.•Utilized advanced Data management functions in Excel to maintain and validate product information for device labels.•Monitored and executed tasks related to design/process changes as part of Product Lifecycle Management (PLM).•Maintained and tracked changes using tools like Track Wise 8 and ensured documentation accuracy and completeness.•Worked on optimizing product dimensions as a part of Engineering Change using CATIA V5, Siemens NX and drafting the product after finalizing dimensions.•Supporting Clients while Executing and Implement the tasks related to Design or Process change for a product Family as a Part of Product Lifecycle Management.

Education

• Mepco Schlenk Engineering College

  Bachelor of Engineering - BE

  2018 — 2022