OBJECTIVE A Biomedical Engineering graduate with 2 years of diverse work experience in medical device industry looking for a challenging full-time opportunity.
EDUCATION Masters in Biomedical Engineering Graduated 2013
Wayne State University, Detroit, MI 48202
GPA: 3.75/4.0
Bachelor of Engineering (Biomedical Engineering) Graduated 2011
University of Mumbai, Mumbai, India 400056
GRADE: FIRST CLASS
SOFTWARE
SKILLS MATLAB & Simulink, Minitab, Visual Studio, AutoCAD, SoildWorks, PSpice, JD Edwards, Microsoft Office
CORE
COMPETENCIES CAPA, Product Data Management, Project Management, Statistical Analysis, GD&T, Good Document Practices, Good Manufacturing Practices, GCP, Understanding of FDA 21 CFR part 820 and ISO 13485, Understanding of Lean Manufacturing and Six Sigma principles.
WORK EXPERIENCE
Manufacturing Development Engineer - Zimmer Holdings Inc., Warsaw, IN
February 2014-present
• Responsible for re-assessment and complaint handling of the manufacturing and design transfer records for Zimmer orthopedic products assuring compliance with the FDA quality regulations.
• Conducting weekly design reviews with the manufacturing and cross-functional teams like Quality, R&D and Regulatory Affairs solving non-conformances maintaining product history files.
• Reviewing and updating BOM’s ,Routers, verification and validation plans, authoring change notices, IQ/OQ/PQ reports, remediating QSR requirements and PFMEA’s ensuring that the product follows relevant SOP’s resolving any non-conformances.
• Initiating changes in the product prints with the consultation of the design owner, mitigating any risks on the overall product complying with quality and regulatory regulations.
CT Clinical Science co-op – Philips Healthcare, Highland Heights, OH June 2013- Dec 2013
• Performed clinical trials providing statistical and feasibility analysis using Minitab on DICOM images with respect to CT number, standard deviation, pixel values and image artifacts.
• Developed a MATLAB code which calculates the calcium score in the specific region of interest and the slice location which was used for my research project with University Hospital (UH).
• Hands on experience with CT scanners and scanning of phantoms to evaluate various results relevant to the research project.
• Performing marketing research on the iMR reconstruction technique for the medical device market and providing inputs to make it more effective to doctors and radiologists thus helping in continuous improvement.
Research Project: Studying and comparing the influence of iterative image reconstruction techniques on cardiac risk level assessment with the standard back projection reconstruction settings by determining calcium score measurements in symptomatic patients in collaboration with University Hospital in Cleveland.
Manufacturing Engineer co-op- Boston Scientific, Spencer, IN Aug 2012- Dec 2012
• Part of the CAPA team for the Urology value stream department. Involved in investigations and providing engineering support for production floor process non-conformance implementing corrective and preventive action plan.
• Developed a SOP for the production floor employees regarding the working of the chart recorder alarm system mentioned in the project below assessing an alternative and effective approach to monitor temperature reducing manufacturing costs, increasing device reliability and improving process measurement capability.
• Provided technical training and troubleshooting instructions to the production floor operators/technicians for the below project reducing manufacturing costs and improving pr...
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