Vikram Rajendran

Experience

• 

  Crisp System India Pvt Ltd

  Oct 2016 - Oct 2017

  Mechanical Designer

  Role: Mechanical DesignerProjects (Hand operated lift).Interacted with the customer and understood the scope of the project.Developed the 3-D models of the mechanical systems using Auto CAD, Solid Works, and Creo. Good knowledge of Gears, Conveyors, motors, and Pneumatic cylinder Calculations.Developed the 2-D drawings of the designed models for manufacturing with GD &T.Prepared user Manual, Assembly Instruction Guidelines, and Service Manuals.Being an active team player in coordinating the project till the machine gets dispatched Show less

• 

  COGENT AUTOMATION LIMITED

  Nov 2017 - Mar 2019

  Design Engineer

  Role: Engineering Design Designed the 3-D models for Special Purpose Machine Design and Development. Projects- (Rivert Insertion Machine, VMI Machine, Inkjet Printing Machine). Good Knowledge in the selection of standard automation components like Cylinders, Grippers, and other power transmission systems. Prepared Bill of Materials list for Manufacturing parts and Procurement items. Identified the suitable Materials and the necessary Coating (Treatment) for the design as per the Application.Dimensioned the Individual Part Drawing and Assembly Drawing for Manufacturing with GD & T.Developed the User Manual, Assembly Instruction Guidelines, and Service Manuals. Supported the cross-functional team till the machine get dispatched Show less

• 

  HCLTech

  Mar 2019 - Aug 2021

  Design Engineer

  Project: MDR (DHF Remediation)Role: Human factor EngineerComponents: Infusion (Buretrol sets, Blood Solution sets, Chemothary sets), Spray set, floseal, Preveleak, Filter (Revaclear, Theranova), Dialysis Machine Accessories (Prisma flex, Ultraline accessories, Ultra lines, and Artisets).Performed Human factors (IEC 62366-1) Assessment on Medical products to identify Medical Device Directives 93/42, EUMDR compliance.Good Knowledge of Formative and Summative Evaluation Studies.Conducted Reviews for Technical files, Gap assessments, and Remediated documentsPerformed Internal Project Quality Assurance (PQA) role and conducted an internal audit, Segregating the defects, Identifying the Root cause of the defects, taking appropriate Corrective Action Preventive Action (CAPA), and giving awareness to the team by conducting lessons learned Sessions.Handled and trained new joiners and coordinated the team to execute the Project plans dynamically.Project: EUMDR (DHF Remediation)Role: Labeling Engineer- (Material, Packaging, and Labeling) COE Components: Surgical Light source (Xenon light source, Cables, and Duo Clamp) and Surgical Instruments.Performed DHF remediation activities as per the approved remediation plan. Collected mandatory Procedures, SOPs, and templates to ease project progress.Planned and Prepared Templates, Knowledge transfer Sessions, and Instruction Guidelines for the smooth the transition of Project ActivitiesPerformed Labeling Gap assessment for Medical Device Directives 93/42, EUMDR compliance with respect to ISO 15223-1, IEC 60601-1 standard, and European Union Medical Device Regulation.Performed DHF Remediation activities for Labels, IFUs, GSPR, and Packaging documents as per the Regulation (EU) 2017/745, Client’s SOP, and as per ISO13485 standards.Coordinating with various teams for achieving on-time delivery.Interacting with clients regarding queries on Project and process requirements for avoiding deviations. Show less

• 

  Tata Elxsi

  Aug 2021 - Apr 2024

  Senior Engineer

  Project: ZB Utah RA RemediationRole: Regulatory Affairs EngineerComponents - Knee Implant (Persona Partial Kee system, Constrained Condylar), and Hip Implants (Femoral heads)Performed gap analysis and remediation on labeling to conform to the latest MDD and MDR requirements.Initiated, reviewed, and Approved (MC) change control Activities.Debt out field Notification to notify the change to all country-specific RA and record and maintain the responses.Ensure the team follows the processes according to standard operating procedures (SOPs) and/or prescribed checklists, Work instructions, Templates, or Forms.Represents the team in Design review meetings for the product and host the weekly status report for the team.Periodically perform a review of the process to find any process gaps and feedback to the team for improvement of the process. Show less