Avinash A

About Avinash A

Lead Engineer with Overall 7 years of experiences. Area of Expertise: Medical…

Experience

1. Lead Engineer

   HCLTech

   Jun 2021 — Present · Tamil Nadu, IN

   1.Responsible to make sure that all DePuy Synthes Joint reconstruction products are complying to the MDR directives. Also responsible for the product management and ECM process• Responsibilities include being a primary point of contact with Client and managing the team for all deliverables.• Creation of applicable standards, usability reports, requirements traceability matrix(RTM) and new risk documents per ISO 14971:2019 for both design and process(Risk assessment summary and Risk management report).• Perform the complaints analysis based on the post market surveillance report which supports to identify the risk level for risk management document.• Perform and support V&V activities includes verification protocols, final reports, rationales/Technical Justification reports.• Conduct review meetings between different stakeholders and finalize the document. • Management and release of all documents in PLM (Adaptiv/Windchill).2.Product Lifecyle Validation• Creating quality reports on Medical Implants and mechanical devices related toHip and Knee Joint Reconstruction.• Recognized as ERS Championship Reward for PLV activity for projectdeliverables in On time and On Quality.• Worked on MDR R&D Support.• Classify the product codes to different material groups.• Creating Test Lab protocol and report for Verification and Validation.• Knowledge On PLM Windchill.• Worked on Commercial Product Development using NJR Standards.• Reviewing the CAD drawings.3. Siemens Point of Care Products• Worked on the project on Siemens Point of Care Products.• Creation of mass upload sheet using G-Master Data.• Segregation of the Data Using SAP.• Generating ECR’S for accommodating design changes.• Strategic planning to complete project within schedule.• BOM Creation, Drafting and Documentation for Engineering Change related Process.

Skills

• Microsoft Office
• Engineering
• C
• Thermodynamics
• Solidworks
• Fluid Mechanics
• Mechanical Engineering
• Heat Transfer
• Ansys
• Autocad
• Finite Element Analysis
• E-Pro
• Manufacturing
• Machine Design
• Solid Modeling