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Mechanical Design Quality

Location:
Kent, Ohio, United States
Salary:
65,000
Posted:
May 17, 2018

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Charan Teja Jannu

ac5hvc@r.postjobfree.com

732*******

PROFESSIONAL SUMMARY

Highly organized, detail oriented, excellent analytical professional with solid judgment and problem-solving abilities, Reliable self-starter experienced in Manufacturing and Quality Engineering with 4+ years’ experience in commerce with all levels of managemental departments with comprehensive knowledge on federal codes 21 CFR 803, 806, 820; ISO 13485, ISO 14971, IEC 62304; dealing on class III medical devices. Rigorously familiar with the system layout designing of mechanical systems along with knowledge on IQ, OQ, PQ and total quality management (including the waste management) with extensive training on 5s and 6s safety in manufacturing and quality engineering. With the overall experience in the various industries related to the healthcare, steel, pharma and special clearance intern at energy utilities. And have experience of guiding and training required for associate engineers on lean and manufacturing principles and set their pace accordingly with value stream mapping of production process. Most expeditious learner in adapting to new methods, policies, software’s as essential.

Working knowledge of product development process

Working Experience in dealing with statistical analysis methods i.e. SPC/Six-sigma. Working experience with various Root Cause Analysis tools i.e. DMAIC, 5 Whys, etc.

Working experience in maintaining products in compliance with FDA regulations, Management information systems(MIS), information quality systems(IQS)

Well versed with handling complaint files in a consistent and timely manner and ensuring that all pertinent information is contained within the file prior to closure and monitors and reports on complaint closure as required.

Skilled in problem solving techniques involving Lean/Six Sigma statistical tools such as: DOE, ANOVA.

Knowledgeable in Risk Analysis and Health Hazard Evaluation related to different device failure mode and risk analysis.

Excellent skills to lead projects to successful completion.

Lead through development, debugging, testing, defect documentation, regression and conclusion.

Great interpersonal and communication skills; strong leadership; experience in engaging audiences of all levels.

COMPETENCIES:

AutoCAD, CREO 3.0, structural and thermal analysis -ANSYS

21 CFR 803, 806, 820;

ISO 13485, ISO 14971, IEC 62304

Design failure mode effect analysis (DFMEA), six Sigma, lean and Kaizen.

Lean and continuous improvement manufacturing principles

Production part approval process (PPAP), MIS reports

Material requirement planning (MRP), statistical and process control (SPC)

Blue print and GD&T proficient knowledge.

Total quality management.

Minitab

IQS,MIS

complaints investigation/handling, CAPA, ISO and post-market surveillance

Standard Operating Procedures (SOPs),

Design History Files (DHF)

Device history records(DHR),device master record (DMR)

Authorizing & Executing Validation Protocols (IQ, OQ, PQ)

Gage Reproducibility & Repeatability Studies (Gage R&R)

Familiar with ERP(AS400) /FPX systems

Expert in MS outlook and PowerPoint

WORK HISTORY

Manufacturing quality engineer 2017 TO CURRENT

I Scientia LLC Warsaw, IN

Creating and maintenance of Manufacturing assembly process on class III medical devices .

Evaluation of the manufacturing process and create the value stream maps in order identify and implement cost saving efforts and scrap waste management.

Creation of the device history records (DHR), device master records (DMR) and other statistical reports for control and validation

Creation of risk management reports using ISO 14971 standards

Creation of standard operating procedures (SOP’S), CAPA and maintenance of Verification of &Validation(V&V) reports

Random inspections of the products by sampling and testing of the product in between the process of manufacturing and frequent meetings with quality department if any Nonconformance issues occurred and maintaining the nonconformance reports

Creation of Value stream mapping by attending conferences with the senior level management and associate level manufacturing and quality engineers

Creation of the reports related to the quality/risk management utilizing the ISO 13485 standards and cross reference of the validation test reports is done by mainating frequent communication with the R&D department

Random inspections and audits on the production floor for the associate level and other production machinists whether they are following 6s safety and ISO 13485 standards and meeting quality standards of the company.

Creating minor Modifications on machine layouts to increase the efficiency of the functionality of the equipment and frequent meeting with the mechanical design engineers for layout adjustments

Continuous track of material and metallurgy, quality, delivery reports from material distributors through ERP system

Creation of PFEMA reports as part of PPAP process for the risk mitigation analysis

Creation of the MIS reports, and cross validations of IQS reports.

Creation of 21cfr 806 removal and modification reports and advancing them to quality department

Creation of 21cfr 820 quality management reports for the quality control and validation department.

Creation of 21cfr 803 MDR reports and advancing them to R&D and quality department

Training the associate level engineers for lean continuous improvement manufacturing principles.

Mechanical Design Engineer 07/2017 to 10/2017

Integra Technologies Wilmington, DE

Creation of mechanical system designs using AutoCAD, CRE0 3.0 for class III medical devices mechanical systems in Agilent Technologies

Creation of 2D production sketches and maintenance of layout/systems design data

Coordinate in-house project, and project engineering/design schedules.

Challenging assignments that include investigating, troubleshooting, and solving a wide variety of mechanical design issues.

Review designs and calculations prepared by other associate designers and performing meetings as required

Studying the reports on Failure analysis studies of equipment as it relates to thermal, loads, vibration performing frequent conferences with the CAM/CAE engineers and project managers

Creation and inspection of design for all utility routines, connections and equipment layout utilizing experience and client provided standards using the lean manufacturing principles and standards of IEC 62034

Maintaining continuous improvement in the layout and improving the efficiency by decreasing the unnecessary costs during final product transfer

Need to perform the statistical analysis on the design data for the research & validation purpose by using Minitab, SAS

Maintaining conference with the senior level management regarding modifications of layout design.

Training manufacturing associates/maintenance personnel on the basics of interpretation of various documents related to Design, blue prints and GD&T

Mechanical Designer 2015(3 months intern)

Bharatiya Nabhikiya Vidyut Nigam Limited (special clearance intern) Chennai,Tamilnadu

Worked directly with scientist’s team(level-III) on the prototype fast breeder reactor exhaust blower to reduce noise level and reduce vibrations and shock loads

Responsible for creative design modification at such low cost using AUTOCAD, CREO 2.0 and ANSYS studies on the pipelines of exhaust blower

Performed Root cause analysis study for vibration of the exhaust blower pipe fixed various problem occurred during the design modifications and initial design of exhaust blower

Performed CAD,CAM and Enova analysis

Creation and maintenance of design history file(DHF)

Performed conferences with the manufacturing engineers and senior management regarding the root causes and other budget studies

Interpretation of the blue prints and GD&T design for the manufacturing engineers/associates and fabricators

Worked on the NANO filtration systems for the filtration of the nuclear waste gases.

Cost effective analysis study is done for new modification is calculated and submitted reports.

Assistant Production associate 2014-2015

Visakhapatnam Steel Plant Visakhapatnam (Andhra Pradesh)

Manufactured different parts such as plain rounds, squares, billets, pig iron, plain wire rods in coil I/II using casting and forging techniques.

Inspected the production line process for damages in pressure valves, direction control valves, motors and other machinery involved in blast and electric furnace steel rolling process.

Interval inspection of parameters dealing with the production in Siemens control systems.

Inspected the hydraulics and pneumatics of the steel rolling furnaces and other equipment involved in the process.

And created IQ,OQ,PQ reports for the machinery as required.

Preventive and other necessary Maintenance of hydraulics if any damages occurred during production process and cross-validation of the coolant mechanism, hydraulic roller cylinders and other equipment involved in process for any damages

Selection of the various grades of oils for the efficient mechanism of the furnace hydraulics and other equipment

Maintain the quality control and other process related specs to make sure product is of desired value by studying grain structures and other metallurgy related studies working close with R&D department

Created reports related to quality and frequent communication with foundry associates and R&D department is maintained.

Manufacturing Quality Associate 2010 -2014

Charan Engineering Works AndhraPradesh and Telangana

Assisted in layout of equipment for Pharma and Biomedical related companies for better productivity and reducing the product transfer costs during the process and post process

Worked on CNC equipment LIKE MILLS, LATHES, WATERJET CUTTERS, plasma spray and grinders etc. And used measuring tools such as, dial calipers, Vernier calipers, micrometers, height gauges, drop indicators, dial indicators, and optical comparators, sphericity tests and other gauges as required for macro and micro components.

PERFORMED Welding Fabrication like MIG, TIG, ARC AND SPOT WELIDNG WORKS

Assisted in installing the Ro water plants and familiar with the micro and Nano filters related to fluids

Erected reactors, boilers and other heavy machinery and assisted other instrumentation engineers

Monitored, calibrated and inspected all machines including CNC’s (G&M codes) for optimum performance.

Used sheet/solid metals for the fabrication related works from scrape

Installed HVAC related equipment including the designing the structure along with the selection of wide range of micron air filters and filtration systems for better efficiency at low costs

Dismantling and assembly of the various heavy machinery and performed maintenance and inspections and created IQ, OQ,PQ reports

Interpretation of Blue print designs for the technicians and other fabricators

Interpretation of GD&T designs for fabricators and labor

Trained other associates on initial startup and 5s safety

Responsible for training on functions for other lower level associates and labor as required.

Education

Masters in Manufacturing and Quality engineering technology-Kent state university, Ohio.

Bachelors in Mechanical Engineer-JNTUH, INDIA.



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