Mechanical / Manufacturing / Quality Engineer

KAMOD KUMAR JHA

US Citizenship

**** ****** *** ************, **, 46241 309-***-**** ******@*****.***

SUMMARY:

Mechanical / Manufacturing Engineer with over twelve years of experience in process development, quality, cost reduction, managing capital projects and medical device manufacturing industry.

Expertise in facility layouts, validation protocols, risk assessment and new product development cycles of medical devices, design control, Gage R&R, assembly, Poka-Yoke, 5WHYs, tool, testing, quality planning, implementation and project management – $500K.

Excellent engineering tools skills, GD&T, and blueprint reading capabilities.

Process Improvement, Failure Investigation principles & Cost Reduction.

Continuous Improvement (CI) projects within manufacturing.

Root Cause Analysis (RCA), APQP, Work Instructions and Time Study Experience.

New Product Management and data analysis of process defects.

Multi project coordination & strong PLC & MES troubleshooting skills.

Strong understanding of CI, lean, six sigma, 5S, 8D, VSA, & kaizen manufacturing processes.

Strong experience in application of Process Maps, PFMEA, MSA and other risk analysis tools.

Strong knowledge of validations (IQ, OQ, PQ), DOE’s, GMPs, FDA, CAPA, and ISO 13485.

EXPERIENCE:

Medtronic (Minimally Invasive Therapies Group) Plainfield, IN

Quality Engineer II November 2016 – Present

Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits ensure that corrective and preventive actions are adequate.

Troubleshooting CNC machine, inspection, metrology and day to day shop floor support. Strong knowledge in CNC environment, GD&T, inspection and measurement, gage design and inspection planning.

Manage the Quality Assurance Program in accordance with FDA Quality System Regulations (QSRs) and ISO 13485 Quality Systems.

Conduct investigation, bounding, testing, documentation, review and approval of non-conformances (NCR’s), CAPAs and customer complaints. Escalation of quality issues as appropriate.

Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process and product risk.

Provide support in the assessment of overall risk mitigation techniques given product classification, potential defect types, defect frequency, process capability, process controls etc.

Provides support to ensure the proper execution of process validation initiatives, as required.

Owens Corning, Thermafiber Wabash, IN

Senior Manufacturing Engineer January 2016 – October 2016

Robotic Stacker: Saved company $250,000 (labor reduction, pallet, shipping, customer complaints, decrease cycle time, and process simplification).

Provided leadership and project management to improve product quality, and equipment uptime and resolving technical problems.

Utilized Root Cause Analysis methods to problem solve process issues and increase equipment reliability, process capability, and improve product quality.

Provided project management to capital projects to ensure on-time and on-budget completion.

Developed and implemented procedures and systems to ensure products consistently meet customer expectations.

Conducted process audits to review critical product characteristics and critical process variables & implementing sustainable corrective actions for process shifts.

Wabash National Corporation Lafayette, IN

Senior Manufacturing Engineer (Contract) June 2015 – December 2015

Electric Floor Driver: Saved company $80,000 (labor reduction, decrease cycle time, and process simplification).

Developed and integrated assembly processes and capital improvement projects to efficiently manufacture trailers.

Leads cross functional teams to implement improvement to existing equipment, manufacturing methods and tooling.

Analyzed equipment downtime to improved reliability and reduced maintenance costs.

Applied technical knowledge to innovate, design, and develop equipment, fixturing, procedures, processes, tooling and automation.

Initiated, developed and managed capital improvement projects including manufacturing equipment, facility enhancements and new product launches.

Smith & Nephew, Inc. (Orthopaedics) Memphis, TN

Quality Engineer II (Contract) August 2014 – May 2015

Developed various inspection techniques and procedures to ensure product integrity to design specifications and implementation of Incoming, In-Process and Final Inspection procedures & operator self-inspection procedures.

Coordinated Measurement System Analysis (MSA) studies, process capability studies and process validations, analyzes data and submits recommendations.

Comprehensive knowledge of product development life cycle, risk assessment, and validation protocols.

Evaluated products, manufacturing processes, assembly processes, and supports quality control activities through training, inspection procedure preparation, and technical support.

Developed process quality plans supplier quality audits, and driving corrective actions and failure analysis efforts.

Utilized appropriate statistical and analytical techniques, such as the application of Failure Mode Effects Analysis (FMEA), hypothesis testing and Design of Experiment (DOE).

John Deere Harvester Works East Moline, IL

Manufacturing Engineer – Assembly (Contract) February 2012 – August 2014

Developed, implemented and maintained methods, operation sequence and processes in the manufacture of parts, components, sub-assemblies and final assemblies. Provided Initial training and certification of operator assembly assignments.

Created and documented manufacturing drawings using SolidWorks BOM and Teamcenter Visualization Mockup and modified operator work instructions for changes.

Worked with various PLC technologies & developed and updated existing code for the equipment’s.

Conducted time studies and line balancing activities for assembly lines operations and maintained accurate labor & cost standards.

Conducted work center audits to ensure accurate layout, tooling, and documentation of assembly methods and provided combine assembly training of new operators.

Coors Tek Golden, CO

Manufacturing Engineer - Plastic Injection Molding May 2007 – January 2012

Developed and maintained documentation, prepare report, blueprint, etc. supporting process and manufacturing improvement.

Developed standardized work plans and proven problem solving techniques to determine root cause analysis for equipment downtime and recommends specific process improvements.

Solid knowledge of a Plastic Injection Molding operation, including PLC troubleshooting, hydraulics, assembly equipment, and automation systems.

Troubleshooting Computer Numerical Control (CNC) machine on Heavy Machine Shop Floor.

Handle customer complaints and implement corrective action when necessary to resolve issues.

Developed and implemented process improvement to reduce cost, product marketability & reliability, improve quality and competitiveness, of specific operation.

Provided continuous improvement of manufacturing processes in to increase efficiency.

Repsol YPF Delhi, India

Project Engineer (Oil & Gas) April 2002 – December 2006

All work was performed in US Standards and International Standards.

Worked on capital projects from concept to start up, including design specification, proposals, economic evaluation, feasibility study and project cost estimates, schedules, vendor selection, mechanical budgets, and final documentation.

Involved in process layout, material handling and testing, methods analysis, equipment design and development, material procurement, process study, and report preparation.

Developed and implemented process improvement to reduce cost and reliability, improve competitiveness, and improve quality and safety of specific operation.

Performed various engineering calculation and analyzed related to process design, and size and selected mechanical and process equipment such as pump, tank, pressure vessel, filter, conveyor, pipeline, compressor, blower, heat exchanger, valve, and instrument.

EDUCATION:

Bachelor of Science, Mechanical Engineering

Magadh University, Bihar, India, 2002

TRAINING/CERTIFICATION:

SAP • Intro to Six Sigma • Green Belt • Yellow Belt • GD&T • Blueprint Reading

Troubleshooting: Taking Corrective Actions • Ergonomic Design Guidelines • Intro to OSHA

Continuous Improvement (CI) • Poka – Yoke • 5WHYs • Lean Tools • PLC & MES

COMPUTER SKILLS:

MS Office Suite • PowerPoint • AutoCAD • PRO-E • PFMEA • DFMEA

SAP • Unigraphics • Outlook • MS Project • Minitab • `MRP System • ERP

Teamcenter Visualization Mockup • Matrix • Gage & Fixture Design • Control Plan

InfinityQS • Vantage Point EMI • PQM Agile • BPCS • E-One

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