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Engineer, Medical Devices, Quality, Complaint handing

East Stroudsburg, Pennsylvania, 18301, United States
January 18, 2018

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*** ***** ******* **., **** Stroudsburg, PA 18301 (607)-***-**** PROFESSIONAL SUMMARY

• Over one year of experience in handling different medical instruments, troubleshooting medical devices, complaint investigation handling, risk management and medical device design

• Skilled in project management and leadership activities

• Proficiency in leading CAPA, GMP, and cGMP protocols EDUCATION

• Master of Science in Bioengineering and Biomedical Engineering December 2017 Binghamton University, State University of New York (GPA 3.63)

• Bachelor of Engineering in Biomedical and Instrumentation Engineering May 2015 Ganpat University, Kherva, Gujarat, India (GPA 3.1) PROFESSIONAL SKILLS

• Math tools: MATLAB, LabVIEW, R

• Medical Standards: ISO 14971, ISO 13485, ISO 10993-1, FDA 21 CFR 803; 21 CFR 820; 21 CFR 11

• Statistical tools: Minitab, Tableau, Orange

• QMS tools: Trackwise, Stratas

• Biomedical Applications: Molecular Imaging, Quality management, Image processing, Atherosclerosis, Risk management and analysis, Prosthesis, Neurostimulation, Complaint handling, Cell cultures, Medical devices

• Other tool: Microsoft Office


Binghamton University, Binghamton, NY Aug 2017 - Dec 2017 Graduate Student Assistant

• Assisted professor with 'Biomedical Instruments' course by grading exams, quizzes, homework and lab work

• Utilized attention to detail when managing confidential student records

• Served as a liaison between students and the professor for any queries or questions related to the course Sandor Medicaids Pvt Ltd., Ahmedabad, India May 2015 - June 2016 Service Engineer

• Experienced in troubleshooting, installation, and maintenance of different medical devices

• Supported all regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design

• Confirmed complaint condition and determined corrective action preventive action (CAPA)

• Evaluated customer feedback and service records for possible complaint

• Acquired knowledge of hardware and work-flow of the Dialyzer machine and recognized their importance

• Helped production unit in developing biomarkers and molecular diagnostic targets that can be utilized for end-stage renal disease patients

• Provided training to junior employees on improving their project management process

• Led group of several sales team members by briefing them about function and importance of different medical devices Shyamal Surgical Hospital, Ahmedabad, India Dec 2014 - May 2015 Quality Engineering Intern

• Investigated product quality issues and determined their root cause, gathered and analyzed data, and implemented corrective actions (CAPA) for reducing or eliminating the cause

• Gained familiarity with Standard of Protocols (SOP) for the maintenance of different medical equipment

• Took part in problem-solving efforts for identifying and resolving recurring and new quality issues, therefore, ensuring safety of the working of different medical devices

• Performed analysis of the data and report results for quality engineering management

• Supported risk analysis and risk management activities

• Assessed whether the risk assessment is covering the hazard in the complaint or not HCG Multispecialty Hospital, Ahmedabad, India June 2014 - July 2014 Junior Biomedical Engineering Intern

• Completed training in operation of different biomedical devices like Defibrillator, CT, MRI, X-ray, Ventilator, Heart-lung machine, Ultrasound, Dialyzer, and many small other types of equipment

• Gained practical knowledge with different technologies being used in every sector of the hospital

• Shadowed and assisted biomedical engineer in the servicing of medical devices, ongoing surgeries, and bimolecular laboratory, therefore, learning the role of a biomedical engineer in the hospital ACADEMIC PROJECTS

Diagnosing Atherosclerosis via Molecular Imaging and Different Strategies for Treating it - Binghamton University Aug 2017 - Dec 2017

• Researched the Pathophysiology and mechanism of atherosclerosis formation

• Implemented the use of molecular imaging for diagnosing the diseased areas of arterial vasculature PAGE 2


838 Seven Bridges Rd., East Stroudsburg, PA 18301 (607)-***-****

• Tested molecular imaging platforms and then were selected based on their individual importance

• Utilized nanotechnology-based treatment strategies by testing on animal models that displayed promise results in treating atherosclerosis Development of a portable magnetic neurostimulation device to prevent Alzheimer's disease progression - Binghamton University Aug 2017 - Dec 2017

• Researched the need behind portable neurostimulation device for the Alzheimer's disease patient

• Stimulated toe tissue with the appropriately designed circuit and with 0.1 mT flux so that the device does not heat the tissue

• Designed portable architecture with several changes in the dimensions of wire and then experimented by keeping it below the toe and under the shoe

Blood Infusion Warmer - Ganpat University Jan 2015 - May 2015

• Built temperature sensing circuit for the patient and blood bag using PCB for measurement of the temperature at the time of warming

• Constructed heating element using very thin coil of mica on the surgical stainless-steel tube that use to warm the blood according to the patient's temperature

• Designed model was used in the hospital for the experiment for warming the blood before being used on the patient LABORATORY RESEARCH

• Strategies on vascularizing artificial tissue/organ In Vitro, Binghamton University Jan 2017 - May 2017 CERTIFICATION AND AWARDS

• Promoted and accredited from Service Engineer to Senior Service Engineer at Sandor Medicaids Pvt Ltd. Nov 2015

• Certification of Excellence when interning at Shyamal Surgical Hospital March 2015

• Shared the first prize in poster presentation in an event at AMA, Ahmedabad on 'My Biomedical World' Sep 2013 ORGANIZATIONS

• Professional Chair, International Connection Student Association - Binghamton University Dec 2016 - Dec 2017

• Management Head and Active Volunteer, National Biomedical Society - Ganpat University Jan 2012 - May 2015

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