Dharamendra Kumar Email & Phone Number

Bengaluru, Ka, In

Hyderabad, Telangana, India

Review, classify, and follow up on product complaints related to medical device safety and effectiveness.Evaluate complaint data, file regulatory reports, and write investigation summaries based on technical analysis.Maintain and analyze complaint records, interact with departments, and ensure compliance with FDA and international regulations.Proficient in 3D modeling of machining, injection molded plastic, sheet metal, die cast, and extrusion parts in SolidWorks; create 2D manufacturing drawings per ASME Y14.5 and GD&T standards, product development, coordinate R&D deliverables, and maintain collaborative relationships with cross-functional teams (Marketing, Quality, Regulatory, Manufacturing Technology, Operations, Software, Electrical).Expertise in design calculations, FEA analysis, DFMEA, risk analysis, tolerance stack-up analysis, and applying GD&T. Knowledgeable in IEC 60601 standards, design for reliability, US MDR, and EU regulatory requirements.

New Delhi Area, India

Participated in all phases of product development, coordinating and communicating R&D deliverables while collaborating with cross-functional teams.Created DFMEA (Design Failure Mode and Effect Analysis) and conducted risk analyses.Designed electromechanical devices and performed 2D detailing using SolidWorks and Creo.Developed designs for various manufacturing processes, including machining, injection molding, extrusion, metal forming, and welding.Created 2D manufacturing drawings in compliance with ASME Y14.5 standards.Proficient in CAD and FEA modeling with SolidWorks, Pro-E, and ANSYS.Developed 3D models for testing fixtures and participated in product testing.

Faridabad Area, India

• 3D Modeling and Design calculation for Product/mechanical Strength testing equipment’s.• Design calculation as per international testing standards for the mechanical product testingequipment.• Dynamic analysis – Motion Analysis using Solidworks.• 3D modeling in Solidworks.• Run FEA analysis for strength calculation.• Tolerance stack up analysis.• Created Manufacturing drawing in Solidworks.• Complete set up and implementation of Solidworks Product Data Management tool (PDM).• Design and FE analysis of special purpose machine, testing machine and fixtures.• Design of rubber components for cable sealing.

Gurgaon, India

Participated in all phases of product development, coordinating R&D deliverables and collaborating with cross-functional teams (Marketing, Quality, Regulatory, etc.).Designed for manufacturing processes such as machining, injection molding, and welding; selected biocompatible materials (ISO-10993).Proficient in CAD and FEA modeling using SolidWorks, Pro-E, and ANSYS.Knowledgeable in medical device design controls (ISO-13485, 21 CFR Part 820) and project management.Developed new medical dental X-ray devices, conducting tolerance stack-up analysis, DFMEA, and risk management.Created 3D models and 2D manufacturing drawings per ASME Y14.5 standards.Performed DFM analysis, draft angle and parting line analysis for various products.Analyzed product risks and hazards using FMEA processes and standards (IEC 60601-1, ISO 14971).Ensured compliance with medical standards and regulatory rules; updated FMEA reports and contributed to verification and validation meetings.Applied statistical techniques, including Design for Six Sigma and Design for Manufacturability.

Ghaziabad, Uttar Pradesh, India

• Discuss with customer for the inputs and requirements.• Create concept design layout and represent the concepts to customer for approval.• 3D modeling of components and selection of standard hardware as per the applicable load.• Run the finite element analysis to check the strength of the design.• Optimize design for material saving and to achieve the required safety factor.• Apply GD & T for tolerance analysis.• To create drawings and designs for manufacturing and complete BOM.

Bachelor Of Engineering - Be, Mechanical Engineering

Master Of Technology - Mtech, Mechanical Engineering, 70.5