Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Vivek Kumar

Warsaw,IN

Summary

High-performing professional with extensive experience with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions. Skilled in reviewing technical specifications, creating manufacturing instructions and developing tools. Strong analytical skills and committed to improving efficiency and effectiveness.

Overview

6
6
years of professional experience
1
1
Certificate

Work History

Manufacturing Engineer

Zimmer Biomet(Contract)
08.2022 - Current
  • Facilitates remediation project efforts to revise existing Bill of Materials (B.O.M) and Router driven by validated process flow in Performance Qualification (PQ) of orthopedic implants, instruments, and components including Class III medical devices.
  • Initiated and handled delegated MCs to update WI s in quality system and Participate with cross functional teams to ensure quality documents are compline to quality standards.
  • Conduct gap analysis for Biocompatibility assessment of medical devices by analyzing high-risk materials associated with process flow being released to production and device history record (DHR) of test articles.
  • Review manufacturing process flow/traveler/router and optimize flow by changing operation sequence and adding or removing operations as required as per Performance Qualification requirements to reflect in JD Edwards and XA system.
  • Adopt product into existing Master Validation Plans (MVP), Operation Qualifications (OQ), and Performance Qualifications (PQ) to reduce costs related to execution while ensuring company's internal requirements and procedures.
  • Review Design History Files and lead efforts to update Design Master Records and control plan as required.
  • Develop fundamental understanding of risk management by reviewing PFMEA and control plans and updating them as required.
  • Develop an ability to read GD&T prints to identify products, surface treatments, and critical to-quality features to ensure inspection criteria and a wide variety of processing applications.
  • Practice Lean six sigma methodologies by driving efforts of continuous improvement and develop fundamental understanding of industry regulations including FDA Quality System Regulations and ISO 13485 .
  • Familiar with ISO 13485:2016, ISO 14971, and 21 CFR 82.

Undergraduate Research Assistant

University Of North Alabama
01.2021 - 05.2022
  • Lead development of Inline Spatial Atomic Layer Deposition Designs beginning with concept and feasibility.
  • Worked both independently and collaboratively in fast-paced laboratory environment.
  • Maintained up-to-date records of research activities and results for future reference.
  • Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations with MS Office tool .
  • Design and develop parts using solid works and perform stress and thermal analysis using Ansys.
  • Applied computer aided engineering (CAE/CAD), and geometric dimensioning and tolerancing (GD&T) to create testing models, samples, and fixtures.
  • Designed parts by modeling, made assemblies with constrains and degrees of freedom and performed and resolved meshes.
  • Generate and modify CNC program using G codes for making prototype in CNC Motion program.
  • Configure and Operated Intelitek CNC Lathe and CNC Bench Mill to perform various operations used in building prototype.
  • Implemented data analysis, analytical calculations, and finite element analysis (FEA) to assess, validate, and compare mechanical properties obtained from experimental results.
  • Researched and identified numerous issues causing pressure leak through vacuum chamber using root cause analysis.
  • Developed test plans for testing prototype and/or development units, analyze test failures and develop/implement design improvements based on test results.
  • Developed and simulated various prototypes, CAD models, and BOM s to test effectiveness of inline spatial atomic layer deposition system.
  • Assist the professor to development of intellectual property generated through R&D activities.
  • Designed, developed, modified, and tested mechanical assemblies and systems by using current tools, analysis techniques, and technologies.
  • Solved engineering problems by analyzing situation and recommending corrective or alternative actions.
  • Analyzed, evaluated, and verified requirements, component performance, and systems by using engineering practice.
  • Successfully completed engineering work in following: technology development, product design, development, and test method development.
  • Conducted tests on equipment and instruments for quality.
  • Maintained and calibrated various types of lab equipment.

Mechanical Engineer

Faberrect Engineers
03.2019 - 08.2019
  • Applied mechanical problem solving skills to develop creative solutions for quality products.
  • Evaluated final product's overall performance, reliability and safety.
  • Identified deficiencies in mechanical processes to develop improvements.
  • Drafted assemblies, models, and other technical drawings.
  • Led product design of boiler parts using SolidWorks and applied FEA for design validation.
  • Used Lean Manufacturing Principles to optimize operator work by evaluating process and conducting time cycle studies.
  • Used power tools to complete rapid prototyping initiatives to iterate and improve existing company product.
  • Improved DFA on assemblies by designing parts with minimal CAD reorientation during assembly and implementing self-fastening features.
  • Used PDM to manage design data and organize BOMs.
  • Produced part and tooling CAD drawings using SolidWorks and GD&T.
  • Developed test plan using design of experiment (DOE) and altered process parameters to intentionally change thermal characteristics using different materials.
  • Responsible for design and modify products with cad 3D modelling software according to customers specifications and ISO standards.
  • Applied mechanical problem solving skills to develop creative solutions for quality products

Mechanical Engineer Intern

Cheema Boilers Limited
06.2017 - 07.2018
  • Developed technical skills through training and shadowing experienced professionals.
  • Communicated with engineering team to discuss methods to improve process and performance.
  • Performed calculations according to standard procedures.
  • Read and interpreted blueprints, technical drawings, schematics, and computer-generated reports.
  • Worked in collaboration of boiler parts design, testing group to perform mechanical engineering design, analysis and coordinated prototype fabrication work in accordance with project requirements.
  • Designed fixtures for testing and product assembly.
  • Used Solid works to construct complex models, parts, assemblies and machined parts, detail drawings with GD&T.
  • Assisted in product developed and design alternatives by performing DFA/DFM and building prototype.
  • Identified process performance issues and implemented solutions.
  • Work with product development teams and with industrial designers from start to finish product.
  • Supported all stages of product development including conceptual design, EVT, DVT, PVT.
  • Learned Reading blueprints for location, position, and dimensions.

Education

Bachelor of Science - Engineering Technology

University of North Alabama
Florence, AL
05.2022

Associate of Science - Mechanical Engineering

Seth Jai Parkash Polytechnic
Haryana, India
05.2018

Skills

  • Technical Tools: CMS, InfoPV, XA, Plot view, AutoCAD, Vault( DHF/DMR database ), ENOVIA, JD Edwards, MS Office
  • Design Tools: AutoCAD, SolidWorks, ANSYS, CATIA, MATLAB, Simulink
  • Other skills: FEA, Six Sigma, C , Risk Management, FMEA, Validation (IQ, OQ, PQ), GD&T, CAPA

Certification

  • Six Sigma White Belt Certification.
  • Solid Works Certification
  • AutoCAD Certification

Timeline

Manufacturing Engineer

Zimmer Biomet(Contract)
08.2022 - Current

Undergraduate Research Assistant

University Of North Alabama
01.2021 - 05.2022

Mechanical Engineer

Faberrect Engineers
03.2019 - 08.2019

Mechanical Engineer Intern

Cheema Boilers Limited
06.2017 - 07.2018

Bachelor of Science - Engineering Technology

University of North Alabama

Associate of Science - Mechanical Engineering

Seth Jai Parkash Polytechnic

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Vivek Kumar