Mechanical Engineer Product Development
Resume:
Anusha V
Ann Arbor, MI-*****
***********@*****.***
SUMMARY
Experience in quality engineering and in writing, reviewing and executing TMVs, DVPs, DVRs IQs, OQs and PQs.
Ability to operate QC tools and perform basic statistical analysis with Minitab.
Competent in Lean Manufacturing Techniques, Statistics and Trending, SPC, FMEA/PFMEA.
Knowledge of Six Sigma and ISO/TS 16949 Quality Standard.
Experience in writing CAPA.
Experience in APQP, PPAP, Process Flow.
Experience in Tolerance analysis and GD&T.
Proficient with MS Office suite and using Solid works.
Excellent public speaking and communication skills.
WORK EXPERIENCE:
Terumo Medical Corporation Elkton, MD
Role: Quality Engineer May 2016-Current
Conducted Gap analysis to meet required standards and regulations. Assisted with the development of quality control procedures and SOPs as required.
Worked on new product test methods development.
Conducted Gage R&R study. Excellent in writing report of the study.
Worked closely with the design team and responsible for conducting process validations on existing and proposed manufacturing processes.
Applied Six Sigma framework to develop process parameters designed to manufacture products resulting in an improvement in process performance metrics.
Analysis of data using Statistical Process Control methods
Support design assurance activities for new product development and collaborated with cross functional teams to facilitate Risk Management activities such as Design FMEA, Process FMEA and Risk Analysis
Experience in writing CAPA, deviations and investigating root cause.
Performed CAPA as well as overseen all aspects of the NCM (Non-Conforming Material). Lead MRB (Material Review Board) meeting to go over NCM and implement corrective action as necessary.
Reviewing test methods, IQ, OQ, Design, MVPs, MVRs, reports, and Scaling plans. Excellent in writing and executing IQ, OQ, PQ protocols.
Mechanical Engineer HMT (PRAGA TOOLS)
Dec’09- May’10 Hyderabad, India
Experienced in the Manufacturing industry in the areas of Quality/Manufacturing, Product Development, CAPA administration, Test Method/Process Validation, Risk Management, and Statistical Analysis
Expertise in Writing, reviewing, and approving Protocols, Final Reports, Master Validation Plan, and Production plan for quality assurance/ product support.
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. Proficient in Lean Manufacturing concepts.
Familiar with statistical analysis methods i.e. six-sigma, Principle component analysis etc. 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. Learning of PC efficiency programming, for example, MS Excel and other MS Office Tools. Working knowledge of GD&T.
Functional Excellence leader driving QMS elements to implementation according to regulations requirements from ISO 9001.
Prepared and performed verification and validation test protocols and analysis following BIS (Bureau of Indian Standards) regulations (ISO 9001) and guidance documents
TECHNICAL SKILLS:
Minitab, Gage R&R
Solid works, 3D modeling AutoCAD
Machine Design, production drawing
Good knowledge and experience in web based Application in .Net
Knowledge of GD&T and SPC
MATLAB.
Knowledge in CAPA, Design controls, DFMEA, PFMEA
Experience with SharePoint.
EDUCATION
University of Colorado Denver, CO
MS Mechanical Engineering December 2015
Chaitanya Bharati Institute of Technology Hyderabad, India
Bachelor of Engineering in Industrial Engineering 2011
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