AYESHA PUNJABI

313-***-**** ac5mwo@r.postjobfree.com https://www.linkedin.com/in/ayesha18/

Summary:

● Motivated Biomedical Engineer highly interested in designing and improving medical equipment that aids in the prevention, diagnosis, and treatment of disease. As a Biomedical Engineer, my goal is to pursue a challenging career in Medical Device Quality Assurance and Regulatory Affairs and become a part of an esteemed organization where I can use my skills, knowledge and experience to contribute in DMRs, Technical files, Design Dossiers, CAPA, QSR’s, ISO, Clinical Study Monitoring, GCP guidelines and Project planning to the growth of the organization.

● Familiar with FDA Regulations: 21CFR Part 820, Corrective and Preventive Action (CAPA), Risk Management, Validations, Design Controls, Root Cause Analysis, Medical Device Regulations, Standards, Recalls, Device Failure Investigations, Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs).

● Familiarity with the medical device development process – cGMP, GLP, GCP, QSR, 510(k), PMA, Informed Consent, IRB review, and ethical principles (Belmont Report) in clinical research.

● Methodical, quick-learner and highly independent team player, problem solver and can troubleshoot scientific issues.

● Certified Lean Six Sigma Green Belt.

Professional Experience and Achievements:

Clinical Engineering Intern, Beaumont Health May 2017 - July 2017 & January 2018 - April 2018

● Collected devices from various departments, cataloged and assigned Quality System Regulation (QSR) numbers to them.

● Contacted manufacturers and sales representatives for equipment returns, reimbursement and complaints.

● Assisted the Clinical Engineering Staff with projects pertaining to medical device acquisition, adverse event investigation and regulatory compliance.

● Assisted the Clinical Engineering and Technology Management staff in the review of medical device incident reports during Med Sun meetings to determine which devices require reporting to the FDA.

● Assisted the Human Investigation Committee (HIC) of the Institutional Review Board (IRB) in the review and/ approval process of the research involving human subjects at Beaumont hospitals and Beaumont facilities. This includes biomedical research or clinical investigation that involves a test article and one or more human subjects, including testing of drugs for human use, medical devices for human use, biological products for human use, electronic products. Volunteer Research Assistant, Healing Hydrocephalus Research Lab, WSU May 2017 - April 2018

● Collecting Cerebrospinal Fluid (CSF) and shunt samples of hydrocephalic patients from Children’s Hospital of Michigan and analyzing it to find out the components in the CSF.

● Freezing the CSF collected from patients and analyzing the PHH (Post-hemorrhagic hydrocephalic) CSF for proteins and cells using Flow Cytometry and ELISA.

● The aim of the study was to understand the reason for over-drainage and therefore this study investigates the dependencies between factors that changes the CSF outflow like Intracranial Pressure (ICP) and Intra-abdominal Pressure (IAP) with external parameters like postural change, heart rate, weight and severity of the disorder.

● Prepared artificial hydrocephalic CSF and injected in pediatric, adult and geriatric rats and inserted a shunt in these rats to find out which of the above parameters are affected.

● The results of this pilot study showed an increase in ICP, IAP and CSF outflow as a function of postural change, heart rate, weight and severity of the disorder in rats with Hydrocephalus when compared to control cohort. This pilot study concludes that the factors manipulating CSF outflow should be taken into consideration in the future shunt systems. Biomedical Intern, Holy Family Hospital June 2016 - July 2016

● Performed daily maintenance of equipment in the OR, ICU, ICCU’s and assisted the Biomedical Engineer in troubleshooting of various equipment as well as paperwork required to acquire new equipment.

● Studied the market and made a comparable analysis of equipment.

● Maintained equipment inventory for all existing and incoming equipment. Radiology Intern, Lifescan Imaging Centre June 2016 - July 2016

● Evaluated MRI and CT machines to check for errors and assisted technician to fix them.

● Acquired an understanding of the preventive maintenance contracts and maintained its database. Research Projects:

Evaluation of Best Knee Implant using LDW (Logical Decisions Software) August 2017 - December 2017

● The objective of this study was to select the best knee implant from the one’s that are already available in the market by comparing certain criteria’s using the LDW software.

● Sensitivity and Risk Analysis was performed using the LDW software on the selected knee implants which in turn helped us to figure out which one was the best based on the criteria’s taken into account. Design of a Microcomputer controlled ECG (Electrocardiogram) Monitor January 2017 - April 2017

● Designed a two-stage differential amplifier using 3 op-amps (Operational Amplifier) which is also known as an Instrumentation Amplifier, a band-pass filter, notch filter, low pass filter and a non-inverting amplifier.

● Designed the amplifier using Proteus software and then set it up on the bread board to get accurate results.

● The result was an ECG waveform with some artifacts. Optimization of the Drowsy Driving System January 2017 - April 2017

● Designed a system that predicts drowsiness based on: EEG, accelerometer, video, and dermal based activity.

● Used a steering wheel joystick and play station (car racing) for simulation, used two BIOPAC – MP36 systems to record EEG, accelerometer, dermal activity and used video camera to record the driver’s facial expressions.

● Post experimental analytics to establish the relationship between brain waves and drowsiness.

● The results of this study shows that the power of delta waves increased whereas the power of beta waves decreased and this confirmed the drowsiness of the driver.

Graphical User Interface to predict seat strokes during crash pulse shapes January 2017 - April 2017

● Determined the displacement of seat stroke based on parameters such as pulse shape and duration of the crash pulse.

● Developed and implemented an algorithm using MATLAB.

● Selecting pulse shapes updates the data on the graph and calculates seat stroke for the time inputs of that pulse shape. Ultrasound Speckle Denoising August 2016 - December 2016

● Developed and implemented an algorithm for noise removal from an ultrasound image.

● Created an image using MATLAB and added noise to it and later denoised it using the algorithm. Microfluidic Device used for Cell Separation August 2015 - June 2016

● Developed an algorithm in MATLAB to differentiate between normal cells and cancer cells after analyzing the sample images of cancer cells.

● Designed a microfluidic channel using AutoCAD and used photolithography to fabricate a microfluidic channel.

● Performed an experiment which used hydrodynamic and optical methods for the separation of cells. Added sample in the channel that would separate normal cells from cancer cells using a micropump.

● Attached gamma camera with the experiment which recorded the separation of cells and then created an algorithm in MATLAB for video processing which determined the difference between normal cells and cancer cells. Computer Skills:

● Microwind VHDL, MATLAB, Pspice, AutoCAD, Proteus, LDW, Precision Tree, MS Office. Education:

M.S. Biomedical Engineering, Wayne State University May 2018 B.E. Biomedical Engineering, Thadomal Shahani Engineering College May 2016

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