TANAYA JOSHI

adc5r2@r.postjobfree.com +1-313-***-**** Detroit, MI

Skills

Medical device diagnostics Equipment Troubleshooting & Preventive Maintenance MATLAB & SimBiology Tool Analog Circuit Design ISO 13485 ISO 14971 Regulatory Affairs FDA Regulations FDA Good Manufacturing Practice (GMP) Regulations Medical Device Reporting (MDR) Regulations Failure Mode & Effects Analysis (FMEA) Corrective & Preventive Action (CAPA) Quality Management System (QMS) Verification & Validation (V&V) Design Control Design History File (DHF) Device Master Record (DMR) Solid works – 3D CAD Modelling SPSS 26 BIOPAC software Result Oriented Analytical & Organizational skills Problem - solving Microsoft Office

Education

Master of Science: Biomedical Engineering April 2020 Wayne State University – College of Engineering – Detroit, MI GPA: 3.55/4 Bachelor of Engineering: Biomedical Engineering Aug 2017 Mumbai University – Mumbai, Maharashtra, India GPA: 7/10 Biomedical Internship/Lab Experience

Vascular Systems Biology and Bioengineering Lab May 2019 - Aug 2019 Wayne State University – Detroit, Michigan, USA

• Developed a mathematical model using MATLAB to study the influence of NO in Neurovascular Circuit to understand the relation between the change of blood flow and volume during neuronal activation

• Developed a mathematical model using MATLAB to study the effects of cellular oxidative stress on eNOS NO production and biopterin ratio

Trainee Biomedical Engineer Nov 2017 - May 2018

Nanavati Super Speciality Hospital - Mumbai, Maharashtra, India

• Arranged training for medical staff on uses, handling and safe usage of medical devices

• Performed routine checking of medical devices to ensure proper functioning of the equipments and ruling out possible malfunctions by performing self-test on the medical devices

• Co-ordinated with Service Engineers to ensure proper servicing and installation of medical devices

• Maintained service reports and installation reports

• Identified and solved technical issues during the breakdown of medical devices

• Performed troubleshooting and preventive maintenance on medical devices Masters Projects

Recording of Bicep muscle contraction electrical activity until muscle fatigue, while recording Jan 2020 - Mar 2020 heart rate to analyze the correlation

Recorded EMG & ECG signals using electrodes and BIOPAC system and processed them by applying Fast Fourier Transform (FFT) to obtain signals in frequency domain. The signals were analyzed at pre-curl, mid-workout and at muscle fatigue. Performed power analysis on these signals using BIOPAC software and plotted graphs for these signals using one-way ANOVA to check the significance at three different time points

FDA – Case Studies May 2019 - Aug 2019

Applied the (1) FDA Standards and Regulations for medical devices, (2) Determined whether the device satisfies the quality control and design control requirements, (3) Applied techniques to verify and validate devices, (4) Applied FMEA technique to evaluate medical devices to identify potential failures.

Design of a Microcomputer controlled ECG Monitor Mar 2019 Developed a microcomputer-based ECG monitoring system by attaching electrodes to a person and obtained ECG signal. The circuit consisted of three stages: Instrumentation amplifier, a filter, second stage amplifier to obtain the desired ECG signal from the electrodes and was developed using analog circuit design

Design of an Instrumentation Amplifier Feb 2019

Developed an instrumentation amplifier to amplify weak signals to reach a desired output. The circuit was developed using three operational amplifiers, connecting wires and various resistors using analog circuit design. This amplifier extracts the signal differences from the electrodes attached to the patient. This circuit was further used for designing Microcomputer controlled ECG Monitor Certifications

• Mini-Course EU MDR 2017/745 April 2020 – No Expiration Date