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MANISHA ARAVALA

OBJECTIVE

Seeking a challenging career position with an organization where my education, experience and people skills can be utilized for the benefit of the team, company and customer. An organization offering the opportunity to work within a group of professionals dedicated to bringing the best possible products to customers.

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SUMMARY of SKILLS

• Accomplished in: New Product Design/Launching, Quality Management systems (QMS), Six Sigma (Green Belt), Production Management, SAP (PLM Machine Design, Sales order planning, Trouble shooting/Problem solving and Budgeting/Estimating.

• Industry Experience: Electro-Mechanical, In-vitro diagnostic (IVD), Plastic and Fabric Manufacturing, Biomechanical, Medical Devises and Manufacturing.

• Data Analysis: Advanced level skills in quantitative data analysis, ASMEY14.5 (GD&T), Tolerance analysis and interpretation

• Software: C, C++, MS Office, QuickBooks, Photoshop

• Operating Systems: MS Windows 95/98/2000/7/XP/Vista, Mac OS X,

• CAD software: SolidWorks (certified), CATIA V5 and AutoCAD.

• CAE software: COSMOS, ANSYS Classic 11.0, ANSYS Work bench 11.0

• Specialty Machine: LabView, Visual Basic.

• Strong verbal and documentation skills. Education was completely in English in India from preschool throughout college.

PROFESSIONAL EXPERIENCE

TKtek, Inc. San Diego, USA 03/11-Present

Manufacturing Engineer

Design (R&D), process development and manufacturing of control systems for medical devices, including cardiovascular catheter, prototype balloon catheters, stents, and stent delivery systems.

Expertise implementing Six Sigma, Lean Manufacturing, SPC, Continuous Improvement, and Statistical Experimental Design activities to improve manufacturing processes and increase efficiencies.

Experience working within FDA, GMO & ISO guidelines (Design Controls) and compliance with internal Quality Systems.

Communicating with supplier to get updated about new technologies and efficient processes. Purchasing and placing orders with the vendors for parts and prototyping the product.

Planning, Designing, tooling and drafting of the device assembly and parts using CAD (SolidWorks), use of Simulation tools to detect motion analysis.

Developing, verifying, testing and validating device from process development through to successful commercialization and reduce costs.

Leading projects from conception through commercial launch of medical devices by developing design and process failure mode & effects documents (pFMEA).

Working with R&D and Quality Engineers to successfully transfer new products into production and improving manufacturing understanding business needs.

Leading process validation activities including writing test protocols, reports, design control documents, preparing manufacturing documents, addressing deviations & non-conformities, utilizing advanced statistical process techniques and SAP (PLM).

Developing and optimizing catheter manufacturing processes involving Machine operations, heat shrinking, laser welding, bonding, plastic design, nitinol materials, and Biodegradable Materials.

Develop and maintain documentation to meet FDA’s and regulatory bodies.

DOUX TECHNOLOGIES PCT LTD 08/09 to 12/09 & 09/10 to 01/11

Manufacturing Engineer

Returned to India and Doux Technologies. Worked once again with a Medical Eqipment (R&D)(as previously while working with Doux.)

Manisha Aravala

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DETROIT MANAGEMENT CONSULTING, MI 01/10 – 08/10

Product Development Engineer

Developed and designed ‘Portable Child Seat Mechanism-(patent pending) to create conceptual pleasing and ultra-sleek module. (Mechanism)

Read and analyzed blue prints, 2D drawings and reports to understand customer design proposals to understand and develop the designs as per FDA-regulations. Responsible for documentation regarding 510K & ISO 9001-9002.

Gained experience with micro machining, plastic injection and sheet metal fabrication process.

Constant and successful communication and coordination with manufacturing department, suppliers, quality, testing to update direct design requirements, improve and changes for technical support.

Effectively used CAD 3D and 2D model generation, assemblies and drafting (GD&T) with dimensioning.

Part of R&D department responsible Design review and evaluating process, and maintaining technical drawings, incorporating engineering orders (EO’s) design overview, reports, documentation and schematics for review and board meetings.

Defined and implemented project plans in accordance with the lean manufacturing techniques, through project start up, execution and completion. Covering the entire product life cycle Sales, Design, Production, Quality and Validation.

Communicated and coordinated frequently across all project disciplines to ensure both team and management was aware of upcoming milestones as well as risks/issues.

Gained Experience working with prototyping, testing, Laboratory Systems and Devices.

Demonstrated applied knowledge of FDA regulations, and Advanced Quality tools such as GD&T, Failure Modes Effect Analysis (FMEA), FEA, Root Cause Analysis and Statistical Process Control (SPC).

Lead a team of prototype designing, testing, project management and documentation.

Prepared and presented Design drawings with evaluated tolerance analysis and with ASME Y14.5 STD (GD&T).

Utilized Ms Office tools and Quick books for documentation, Created requirement sheets and reports.

Responsible for the design and Development of various parts via SolidWorks and Catia V5.

DOUX TECHNOLOGIES PCT LTD 08/09 to 12/09 & 09/10 to 01/11

Manufacturing Engineer

Ensured structural analysis on development of manufacturing process to develop Medical Equipment using machine operations, various forming and plastic injection.

Completed designs via Solid Works, Catia V5, PDM, 3D solid-modeling and 2D drafting.

Performed analysis on the verification and the validation of the actuators.

Working with supplier to understand and update specification and parts ordering and tracking.

Gained experience with research, development in advancement of a concept to prevent medication errors and variations in an IVD envirnoment.

Designed and documented for design progress, maintained all revisions and ECNs.

Took a lead role in the preparation, reporting and documentation for Board meetings, design reviews and test protocols.

Prepared mechanical drawings, sketches, descriptions, specifications and supporting document including bill of material (BOM) in compliance with regulatory bodies (FDA).

Gained experience in Statistical process control and implementation lean manufacturing techniques.

Schedule meetings and assigned job duties to varied manufacturing departments.

Completed engineering involved in generating Soldering and fabrication.

Modified drawings, update database of documents of recording data and drawings.

Served as a Company Liaison for countries Japan and USA.

Completed Geometric Dimensioning & Tolerance ASMEY14.5 (GD&T) training.

Manisha Aravala

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AGI GLASPAC 05/05 to 06/09

Mechanical Design Engineer Design and development of high volume equipment manufacturing for Glass bottle, Glass container and plastic components manufacturing used in medical device.

Coordinated with material Managements requiring Equipment Molding which include using SolidWorks, Pro-E and COSMOS.

Involved in designing of Blank & Blow parts for glass bottle manufacturing for a high volume production.

Worked with Designing Mold for Injection Molding for plastic Component Manufacturing.

Applied and gained experience in implementing automized mechanisms for development of the production cycle. (Automization).

Designed gages utilized to check the bottle necks (Sensors) designed with alloy.

Perform Load and stress calculation to check reliability and feasibility for process design.

Coordinating and Communicating design changes with product engineers, suppliers, quality, manufacturing, program management personnel and sales for customer specifications.

Designing and detailing with hand sketches 2D and detailed 3D designing of Jigs and Fixture and assemblies and part models.

Documented, developed, audited procedures, process validation and practices for QSR compliance and ISO 9001 certification.

Transfer of product design into production and successful commercialization.

Analyzed data and documentation of development changes in design and manufacturing process.

Gained experience in understanding and interpreting test plan, testing and updating report to

Implement test improvements and changes.

Utilized Microsoft Office tools for documentation, Schedule, report and maintain data.

Collaborated with marketing departments to determine requirements of the project and updating change order notice to various departments and process changes.

EDUCATION

BSME, UNIVERSITY OF OSMANIA, VCE, India

(Industrial Production Engineering)

Rated at the top school in the state

Little Flower Junior College, Hyderabad, India

MPC [Mathematics, Physics and Chemistry] Intermediate Degree

NOTABLE ACHIEVEMENTS

• Designs were reviewed and selected by SIEMENS.

-In a contest conducted by SIEMENS –“SOLID MODELLING CONTEST” my designs were selected among 150 contestants in 2008 Oct.

-Designed and developed the concept of Differential Steering Systems.

-Prepared and delivered presentation of the design aspects.

-Submitted documentation of the entire concept.

• Final Project on-‘Attainable Accuracies in a CNC Machines’

-Research and Development of CNC machine accuracy tests.

-Designed and Created prototypes to check the accuracy of CNC machine.

-Developed, performed and verified accuracies of CNC machine which are certified by the government.

• Project on ‘Glass bottle formation process - Design Perspective at AGI-GLASPAC

-Assisted the Design manager to design glass bottle for mass production.

-Worked closely to create an automated technique to implement manufacturing of 3D components.

-Prepared and Submitted documentation on automation techniques.

Manisha Aravala

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• Achieved a unique design for “Car-dashboard” was selected for finals at Shastra-Technical festival.

-Research of car interiors and implemented asthetiques to design a vehicle cockpit.

-Worked closely to create detailing and description of the design aspects.

-Prepared and delivered presentation of the design and specifications.

• Presentation on “Solar cells” in JBIET.

-Research on solar cells and development.

-Prepared and presented the documentation based on the research.

• Presented design’s for 3D-Model Gallery at Vasavi College of Engineering.

-Prepared 3D components on Solid works and presented.

References Shall Be Furnished Upon Mutual Expression of Interest

CONFIDENTIAL RESUME

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