Biomedical Engineering,Clinical Rsearch, product development scientist

Summary

Highly motivated engineering with a background in biomedical engineering with several years of experience in product development, clinical research studies, and test method development, looking for a position in healthcare area.

Pursing a master degree in Business and science, concentrating in engineering management from Rutgers University.

Professional Profile

Systematic approach to product development in analyzing technical data and understanding consumer perceptions.

Creation of technical consumer models that allow for developing effective product designs and predictive models.

Excellent analytical and technical skills and expertise in troubleshooting and problem solving.

Experienced in cGMP documentation and maintaining accurate and complete records of all work.

Designed and performed Test Method Validation and Equipment consistency verification.

Experience in the design and execution of in vivo and in vitro studies

Education

Master of Business and science concentration engineering management Expected Graduation May 2018

Bachelor of Science, Biomedical Engineering, and Minor: Psychology May 2010 GPA: 3.40

Rutgers the State University, New Brunswick, New Jersey.

Experience

Johnson & Johnson / Scientist-I

Skillman, New Jersey January 2011 – June 2014 (Contract)

Collaborated with cross functional team to design and execute clinical research studies to better understand product efficacy, consumer perception and acceptance of products, and provides support for new and existing claims for medical devices

Coordinated with external experts to optimize test equipment for specific clinical study to increase data accuracy to 95%

Analyzed consumer clinical data using statistical methods

Designed simulation model using imaging techniques to provide simulating techniques to represent real life usage

Led multiple projects through multi stages, by developing and designing test method

Optimized existing test method apparatus, operating procedures to improve accuracy and reproducibility results to be representative of real life human use of product and improve accuracy and repeatability by 95% of the time

Created and documented design of experiment for test method under GDP

Collaborated with Global Regulatory, Quality, Medical Affairs Teams and other cross-functional departments to prepare documents for products release, and supported the launches for 11 medical devices products on time of the strategic plan

Worked with the technical lead in preparing the required FDA Compliance documents for Class I and Class II medical devices products. Compliance with relevant Codes and SOPs of all promotional claims.

Designed, developed and tested new prototypes for medical devices based on consumer/clinical in-vitro test data

Expertise in creating Batch Record Book, product and raw material specifications for engineering devices

Revlon Research Center / Safety & Regulatory Chemical Analysis Assistant

Edison, New Jersey Sept 2010 – January 2011 (Contract)

Catalogued and updated formulas into the Voluntary Cosmetic Registration Program Database

Prepared drug stability samples to be sent for external safety testing

Research Assistant - Arterial Plaque Dome Model Exhibits Wall Vibrations (Advisor: Ph.D Gray Drzewiecki)

Rutgers University, New Brunswick, New Jersey Sept 2009 - May 2010

Created non-invasive diagnostic techniques to detect the presence of arterial abnormalities, resulting in cost-minimization

Wrote and computed MATLAB programs to study the stages of atherosclerosis

Modeled and compared the relationship between pressure and area of healthy versus diseased arteries

Skills

Laboratory: Instron, Computerized Tomography (CT) Scans, Prototype Preparation, Specimen Preparation, Viscosity Analysis, Humidity Chamber Testing, and knowledgeable in SOP/GMP/SMP/GCP

Computer: Microsoft Office, Osirix, PMod, Adobe Photoshop, MiniTab, Tobii, MATLAB and Mac/Windows Operating Systems

Languages: Fluent in English and Arabic and Knowledgeable in Spanish and French

Publications:Anderias Sara, Marissa Berkowitz, Nicole Ciula, Stephanie Yang, and Gray Drzewiecki, Ph.D. "Arterial Plaque Dome Model Exhibits Wall Vibrations." Northeast Bioengineering Conference (2010) .IEEE.26-28 Mar. 2010. Web.

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