Engineer Mechanical

VISHAL JOSHI ********@*****.***

** ****** *****, *******, ** 07012 201-***-****

Summary:

• Project management experience on Product Design Verification and Process Validation using compliance 21 CFR, QSR, GMP, ICH, FDA and ISO13485 guidelines in the application of medical devices.

• Sound hands on experience and demonstrated knowledge on IQ, OQ, PQ, CAPA, FMEA, MSA and GR&R.

• Knowledge of statistical analysis techniques such as Minitab, analysis of cause and effects

• Strong troubleshooting skills with lean manufacturing concepts like SPC, KANBAN, KAIZEN and JIT.

• Proficiency in 2d cad drafting and 3d modeling experience using AUTO CAD and PRO-E respectively.

• Quick learner, goal oriented, self-motivated, independent, hard worker and dedicated to work.

Experience:

Becton Dickinson & Company, Franklin Lakes, NJ May 10 – Present

Engineer

• Writes protocols and reports to challenge the critical parameters related to design verification & validation, assures that proper channels approve protocols.

• Interacts with all affected personnel in the execution of protocols and gathering the test data. Ensures that all test data gathered and recorded in accordance with cGMP requirements and industry trends.

• Apply statistical skills on Minitab on data trending analysis on a linear regression, box plot, scatter plot, power curve, histogram, predictive analysis for shelf life. Also, provide sample rational and calculation on Minitab to find out correct sampling plan for Design Verification.

• Analyzes data to ascertain that it meets the related protocol acceptance criteria. Writes deviation reports as required upon failures to meet protocol acceptance criteria.

• Assist project leaders to drive projects, write design review minutes, memo, project charter, design development plan, time line and achieve priorities.

• Successfully completed multiple legacy projects such as Code extension, Line extension and packaging change using Design Control procedure.

• Constantly working with WW engineering team for delivering customer need in adequate time with maintaining good DHF documentation for FDA and ISO audit.

• Using Design Control procedure to launch new product configuration and develop existing product with multiple configuration of medical devices.

• Find quality issues and implement strategy by using CAPA, FMEA, DOE, Engineering study, GR&R and MSA for improvement and future prevention of failure.

• Provide support and input for cost reduction and improvement of new stability and design control procedure for WW shelf life aging study.

• Experience in development and testing on SCF packaging and non-sterile packaging for medical devices.

• Effective usage of SAP and QDMS tools for manufacturing and operational documents such as BOM, Specification and Drawings.

• Provide support to CQS team to resolve customer complaints and issues related to shelf life and quality of products.

PBS INC. Stratford, CT Jan 08 – Aug 08

Engineer (Intern)

• Produced 3D CAD models and 2D detailed drawings for injection-molded parts using Auto cad and Pro-e.

• Sound familiarity with geometric tolerance and dimensioning per ANSI standards preferred.

• Worked on technical documentation to support product development and customer needs.

• Review bills of materials for product assemblies and enter them into the manufacturing system.

• Support Operation manager to solve engineering problems related to the customer’s requirements.

GHCL LTD. India June 05 – June 07

Mechanical Engineer

• Worked as a Quality Engineer on KAIZEN, KANBAN, JIT and SIX SIGMA project implementation for mass production.

• Conducted audit of process and tested to verify implementation of corrective actions and current use of procedures.

• Investigated quality issues using root cause analysis technique such as analysis of cause and effect, coordinated reviews with cross-functional team to help determine corrective actions, and publishing reports as required.

• Conducted statistical analysis of product characteristics and processed parameters to support determination of process capabilities, as well as validation of effectiveness of corrective actions.

• Worked in Quality Department for continuous improvement efforts and maintained compliance to ISO 9001, OHSAAS 18001 and ISO 14001 for quality requirements.

• Supported Quality Control Lab to improve test accuracy and instrument reliability through preventive maintenance, calibration, Gage Repeatability and Reproducibility, MSA study for testing.

ANUP Engineering Ltd. India May 04 – May 05

Engineer (Intern)

• Mechanical engineering design experience using Pro-e with hands-on experience working with process

documentation and design of manufactured/assembled products.

• Performed basic stress and force analysis using ANSYS for performance of the product.

• Wrote and analyzed requirements, functional specifications, design specifications, test plans, and documentation.

• Generated product-engineering data, wrote work instructions and developed training & maintenance of product.

• Created, updated, reviewed, and approved manufacturing documentation.

• Reviewed and resolved manufacturability issues with production personnel.

• Designed developed, analyzed documents and supported testing of products, systems or subsystems.

Education:

• Master of Science in Mechanical Engineering - University of Bridgeport, CT Dec 2009

• Bachelor of Engineering in Mechanical Engineering - Gujarat University, India May 2005

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