Ph: +1-512-***-**** email@example.com
Over 2 years of experience as a Manufacturing Engineer with expertise in Process validation, Quality improvement and statistical analysis.
Good working knowledge on FDA, ISO, ASTM and ISTA Packaging Standards.
Experienced in FDA 21 CFR Part 11, Part 820 regulations and ISO 13485 and ISO9001.
Familiar with statistical analysis methods i.e. six-sigma, Principle component analysis etc.,
Performed Process validation (IQ, OQ, PQ, TMV) for different assembly lines.
Familiar with various Root Cause Analysis tools i.e. DMAIC, 5 Whys, etc.
Hands on experience in creating the Design History Files (DHF) and updating them as per the changes made in the due course of design of the product line.
Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP and process mapping.
Experience using Statistical Process Control and process analytics.
Ability to assist in test method/setup optimization, test fixture optimization, test data and yield.
Analysis and real-time investigation of yield and test issues for both in house and outsourced assemblies.
Experience in SolidWorks 2D and 3D modeling experience and experienced in simulation software ANSYS.
Strong knowledge of Microsoft Office Suite as well as statistical software packages (Minitab).
Strong foundation knowledge of statistics, regression analysis, and design of experiments.
Subject matter expertise in packaging engineering or device/combination product assembly.
Bachelor of Technology in Mechanical Engineering GPA :3.45
National Institute of technology, Raipur, India- May 2015
Master of Sciences in Industrial Engineering GPA 3.23
St. Mary’s University, San Antonio, Texas- Dec 2017
Technical Skills: Lean/Six Sigma, DFMEA, PFMEA, FMEA, 8D, 5S, KANBAN, Corrective Action and Preventive Action (CAPA), Root Cause Analysis, GAP Analysis, DVP&R, PPAP, SPC, DOE,APQP, MSA, QC.
Validation: FMEA, Lean/Six Sigma, Validation plan, Audit Trails, Validation Summary Report, System procedures, GAP analysis, QMS, GDP, GMP, GLP, Risk Assessment.
Product Design & Analysis: SolidWorks, CATIA V5, Pro-E, ANSYS, GD&T, AutoCAD.
Standards: OSHA, ISO, ASTM and ISTA, FDA 21 CFR Part 11, Part 210, 211,820.30,820.75, ISO 9001:2015, IATF 16949:2016 and ISO 13485, 14971.
Computation & Simulation: MATLAB, Microsoft Suite, Autodesk Fusion 360, MS Excel, ARENA, R-tool, S-tool.
SPC Tools: MINITAB v18
Manufacturing Processes: Fabrication, CNC, DFMEA, Injection Molding, BOM.
IE Skills: Time Study, Motion study, Process Planning, ERP, Work Standardization, Value Stream Mapping, Line Balancing, Facility Design & Planning, Tooling, JDE
Immunomedics, Inc., Morris Plain NJ, Manufacturing Engineer Intern Jan 2018-Sep 2018
Performed commissioning and qualification activities.
Drove supplier development by assisting them in developing problem-solving control tools such as: 8D, process mapping, FMEAs, mistake proofing, SPC, Process Capability/Cpk, GD&T, Gage R&R, etc.,
Audited injection molding processes against the Master Process & Control Plans.
Developed and maintained QAR (Quality Assurance Report) books.
Assisted in procedure development and maintenance, quality validation after mold repair, including capability studies, Gauge R&R, first article reports, etc.
Developed and maintained SPC database.
Ability to oversee the documentation of nonconformities, trending of company processes, as well as documented nonconformance’s into the Corrective Action/Preventative Action (CAPA) program.
Responsible for conducting and closing investigations, determining root cause, and implementing/closing CAPAs.
Designed jigs and fixtures in solid works as a part of tool setup in the new manufacturing facility.
Maintained, reviewed, and updated the company on the latest standards (ASTM/AAMI), guidance, and applicable requirements from regulated bodies (FDA/ISO).
St. Mary’s University, San Antonio, TX, Research Assistant Jan 2017-Dec2017
Engaged in the project with a focus on providing alternative solutions to efficient handling of a safe deposit box in the bank vault area.
Performed Ergonomic analysis by reviewing materials handled by employees.
Analyzed equipment utilized from a biomechanical perspective and provided cost-effective solutions to the bank management with the goal of reducing damage to the clients’ property.
Simplified complex specifications into logical design requirements.
Analyzed and planned work force utilization, space requirements and workflow.
Increase in Productivity of the employee after suggesting the experimented methods of handling the safety deposit.
Toyota Automobiles, Raipur, India, Automobile Engineer June 2015-Dec 2015
Responsibilities include definition of requirements, tooling, validation testing, and launching in an assembly plant during the development of exterior lighting products throughout a vehicle’s life cycle.
Performing design failure mode effect analysis (dfmea) for the new vehicle lighting systems.
Driven a cross functional team that includes lighting suppliers, studio, purchasing, manufacturing, and quality functions.
Demonstrating clear communication and project management skills with robust solutions.
Generating and executing technical solutions for exterior lighting components to support new vehicle programs.
Performing complex engineering evaluation analysis and working cross-functionally to implement cost savings, product improvements, and to support prototype and production build activities.
National Institute of Technology, Raipur, India, Sr. Design Project June 2014 – May2015
Served as part of a five-member team, under the direction of PhD Srinivas G, analyzing deformation of titanium alloy in pin on disc apparatus using finite engineering methods (FEM).
Delivered a solution to aid manufacturers in the design of improved products and maintenance plans to avoid potential failures and avert financial losses.
Utilized ANSYS and Solid Works to stimulate wear and consequent useful life prediction of pin on disc.
Analyzed data through ANSYS and presented findings at the senior design presentation.
Worked on the real lab experimental set up of the pin on disc apparatus.
BHEL, Hyderabad, India, Manufacturing Engineer Mar 2012- June 2012
Observed manufacturing and working process of High Pressure (HP) heater and worked on design of HP water heater.
Ergonomic issues of the workers are improved with the application of OSHA work place safety standards.
Formulated process drawings, process flow charts that contributed for new product designs and modifications.
Managed the coordination and overall integration of technical activities involved in Product development projects.
Assisted in launching New product and its design and development.
Assisted with re- organizing plant layout, workstation design and assembly lines.
Advised on efficient packing processes, procedures, innovations in packaging materials as improvement opportunities.
Conducted Time and Motion studies in the factory.
Evaluated processes, procedures, data, tools and fixtures to identify causes of specific quality & manufacturing issues that may affect production and quality, then worked with Engineering and Production to improve processes, tools and fixtures.
1.Lean Six Sigma Green Belt
2.Certified lean management professional
3.Quality Management System IATF 16949:2016
5.Quality Core tools (FMEA, PPAP, APQP, MSA, SPC)
6.Six sigma champions certified
7.Industrial design foundations
8.Staying lean with KANBAN
9.Lean manufacturing and World class manufacturing
10.Problem solving methods (8D, PDCA, A3, Quality circle),7QC,7QM, Root Cause Analysis.
11.Toyota Production system and Lean manufacturing.
12.Total Quality management and its 8 pillars.
13.Total Productive maintenance and maintenance management
14.Lean six sigma yellow belt.