MANISHA SHAH

yzu44p@r.postjobfree.com/ 330-***-****

*** ** ***** ***, *****, FL-33025

WORK EXPERIENCE

Cordis, Johnson & Johnson

Consultant Biomedical Research Engineer II June, 2009 – Current

Convergent Product development projects

• Lead a team to design and write protocols as per CFR 820 regulations, to test functional attributes of Class III medical devices (Drug-Eluting Stents and Guided Catheters, coating material).

• Assessment of test systems capability, support sustainability of test systems (troubleshooting; risk mitigation; improvement initiatives [next generation]; training).

• Work as part of the development team, to bring new products to market on time.

• Assist with the planning and execution of Design of Experiment (DOE) activities to establish product or process specifications.

• Provide input as a part of team on product and process designs to ensure manufacturability.

• Interface with the quality assurance team and manufacturing team in the development of product test strategies.

• Support and perform test process validations and documentation.

• Conduct, coordinate and aid in formal validations including test requirement development, protocol development and execution, development of formal documentation packages.

• Use statistical methods as part of process and test validations.

• Prepare written procedures, proposals, and reports in accordance with cGMP/FDA/ISO-9001 guidelines and regulations.

• Brought-in and developed analytical tools based test methods using various analytical tools: SEM, Particle counters as per FDA guidance for device testing in industrial setting.

• Statistically analyze related data using MINITAB

• Literature review from in-house lab notebooks as well as from various publications

University of Maryland, Artificial Organ laboratory, Baltimore

Research Engineer May, 2008 – Feb 2009

Clinical, Post-clinical, Animal projects:

• Experience performing on-bench fluid-dynamics and Biocompatibility (ISO 10993) test on Electromechanical devices ( JARVIK LVADSTM and Levitronix’s Hemolyzers)

• Executed clinical research in a cross-functional team of cardiac surgeons, technical engineers, and biologists.

• Improvise the existing Hemo- biocompability protocols using tools such as DOE and Fault tree analysis.

• Participate in the development of mechanical, physical, chemical or biologic test methods and test protocols; perform tests and record information; provide reports required to meet Design Control requirements.

• Generate basic statistical summaries and reports from collected data

Clinical Tissue Engineering Center, UA, Ohio

Research Assistant 2006 – 2008

• Concept designing of Class III medical device based on biomaterial.

• Perform detailed design analysis.

• Designed, developed and characterize biomaterials (poly-peptide based polyurethane) based medical devices, and performed prototype tests on poly-peptide based polymeric meshes for use in field of tissue engineering.

• Gained experience in naturally occurring biomaterials (collagen) development and characterization.

• Conducted materials testing (ASTM) and medical device characterization experience, specifically mechanical testing (Instron or similar) and medical device biocompatibility (cell culturing)

• Experience with SEM, TGA, FTIR, GPC and other analytical biology/biochemistry methods.

MCS Printed Circuit Boards Inc, India 2004-2005

Engineer

• Designed and developed single as well as double sided printed circuit boards

• Troubleshooting and inspection

• Production lines process involved etching, molding lamination, circuit inspection

• Customer interface and technicians supervision.

EDUCATION:

Masters in science, Biomedical Engineering

University of Akron Aug 2008

Bachelor of Engineering, Biomedical Engineering May 2005

Manipal Academy of Higher Education, India

AWARDS AND PRESENTATION

• Poster Presentation at Johnson and Johnson Scientific Symposium, 2009. “Hydrophilic particles analysis”; Manisha Shah, et. al, Cordis, JNJ. Nov, 2009

• Best Graduate poster presentation award for research topic “Biodegradable porous polyurethane scaffolds”. Author : Shah, Manisha ; Lopina , ST. ( UA)

International society for pharmaceutical Engineers (Great Lakes Chapter regional meet)

Feb 2007

Software SKILLS

• MINITAB, MATLAB, MATHCAD , SolidWorks, LabView ( proficient)

• C, C++ ( Familiar)

• Microsoft excel, Microsoft PowerPoint, SAS( Advance)

REFERENCES: Available on Request

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