Sriram Gaddamanugu

*** *********** **. *******, ** acs9rr@r.postjobfree.com 336-***-****

Profile

Biomedical Engineer with a strong background in early stage Medical Device Development and Design Verification/Validation Studies. Proven ability to generate quality work, under pressure, in both team settings and unsupervised environments. Quick learner with strong attention to detail.

Education

North Carolina State University – Raleigh, NC Graduated: May 2015

Biomedical Engineering, B.S. Concentration in Biomaterials

Lean/Six Sigma “Green Belt” Certification Received: May 2015

Technical Skills

Industrial: Medical Device Development, FDA QSR, ISO 13485, Lean/Six Sigma Implementation, GMP & GDP

Design/Modeling: SolidWorks CAD, Minitab 17, Image J, LabVIEW

Programming: Proficient in MATLAB and Microsoft Excel.

Professional Experience

Novocor Medical Systems, Inc. April 2015-November 2015

Research and Development Intern

Supported product development and design verification testing for an early-stage medical device company developing its core product and submitting for FDA approval.

Actively involved in the planning and execution of human factors validation testing for the device.

Conducted testing and generated accompanying documentation in order to justify implementing a major design change to the final device, just weeks before production.

Evaluated feasibility of incorporating several cost reduction strategies for the second generation device.

Coordinated with new suppliers to source materials needed to test second generation prototypes.

Collaborated with patent attorneys in converting the company’s provisional patent to a PCT application.

Generated test protocols and reports to ensure the project’s compliance with relevant FDA regulatory guidelines and ISO/IEC Standards.

Wake Med Hospital, Emergency Services Department August 2014-May 2015

Product Development Engineer, Senior Design/Lean Six Sigma “Greenbelt” Project

Created a novel laryngeal intubation tube that is capable of accurately monitoring the core body temperature of cardiac arrest patients requiring therapeutic hypothermia.

Yearlong team biodesign project that required compliance with ISO and FDA regulations in developing a device to address unmet stakeholder needs.

Skills Learned include Maintaining Design History File, Stakeholder Analysis, Needs Assessment, Device Fabrication, Quality Assurance, Design Verification, and Intellectual Property Management.

North Carolina State University, Department of Biomedical Engineering Summer 2014

Research Assistant, Dr. Ke Cheng’s Lab

Studied the regenerative potential of cardiosphere-derived cells in patients affected by heart attacks

Independently designed and conducted experiments to evaluate the therapeutic value of cardiac stem cell-derived exosomes on hypoxic heart tissue.

Manipulated exosomal surface to boost the targeting efficiency of exosomes to damaged heart tissue.

Wake Forest University, Department of Microbiology and Immunology Summer 2013

Summer Researcher, Dr. David Ornelles’ Lab

Developed and applied methods of immunofluorescent labeling and microscopy to analyze chronically and acutely infected white blood cell lines.

Performed high-throughput multicolor fluorescent imaging to evaluate the presence and localization of several adenoviral proteins of interest.

Created customized programs in Image J and R Console in order to expedite statistical analysis.

Volunteer Work

Community Care Low-Income Health Clinic – Winston Salem, NC 2012-2015

Volunteer Nurse

American Red Cross, Northwest North Carolina Chapter – Winston Salem, NC 2009-2011

Member of Board of Directors (2009-2010), Youth Program Volunteer Director

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