Medical Engineer

Sukaina Merchant

*574-***-*****682-***-**** * *****************@*****.*** * https://www.linkedin.com/in/sukaina-merchant-0b339612a/ EDUCATION

UNIVERSITY OF TEXAS AT ARLINGTON, Texas

Masters’ of Science in Biomedical Engineering, May 2018. GPA: 3.6 UNIVERSITY OF MUMBAI, India

Bachelors’ of Science in Biomedical Engineering, June 2016 PROFESSIONAL EXPERIENCE & PROJECTS

REGULATORY & QUALITY ASSOCIATE

Zimmer Biomet, Dec 2018 – Present

Reviewed labelling, package inserts and surgical techniques for compliance with US and International regulations.

Reviewed product changes for impact on regulatory status of the product Participate in Material Review Board (MRB) process and help with timely disposition of non-conforming products as Sort, Scrap, Return to Vendor or Rework as appropriate. Manage and coordinate the CAPA review meetings, by following up on action items and ensuring they are completed on a timely manner. Also review actions to make sure they are effective and compliant to 820.100 Reviewed existing documentation and documents findings. BIOMEDICAL ENGINEER

KDA Hospital, July 2015 – July 2016

Ensure proper safety standard for all medical equipment used at hospital facility. Assisted in procurement and installation of Medical Devices. Assisted in equipment inventory documentation including work order management, quality management, patient safety, risk management.

Supported technical & operational activities of installing biomedical equipment and provided training to new nursing staff on medical devices installed in other departments. Maintained documentation for biomedical equipment and updated the inventory of all types of medical equipment installed in the hospital.

Followed up with vendors for any breakdown under annual maintenance contract equipment. Conducted audits to ensure compliance with hospital standards. BIOMEDICAL INTERN

Nanavati Hospital, May 2015 – June 2015

Reliable for preventive maintenance inspection and electrical safety testing and corrected problems as encountered.

Used available test equipment to test functioning of all medical equipment, including troubleshooting functional problems and repaired medical devices.

Supported inspection and servicing on various hospital equipment such as ECG, Ultrasound machines under the supervision of head service technician.

Participated in staff meetings, wrote meeting notes and ensured that actions items were tracked and resolved in a timely manner.

TRADITIONAL 510(K) DRAFTING

University of Texas at Arlington, Jan 2018 – May 2018 Documentation of a Traditional 510(k) for a Class II medical device was accomplished. The 510(k) was documented for a home pregnancy test which was compared to its predicate from the FDA database.

Substantial equivalence was proved and the draft was submitted for over the counter use for the device. NERVE CONDUIT IMPLANTATION TO RAT SCIATIC NERVE

University of Texas at Arlington, Jan 2018 – May 2018 Fabricated a 3D scaffold conduit using SolidWorks and implanted in male adult rat for sciatic nerve regeneration. The conduit was designed to allow for surgical procedures for installation to improve the regeneration of an injured nerve by preventing the invasion of scar tissue. The 3D conduit demonstrated a strategy for nerve regeneration that could be implemented in the days to come. DRUG RELEASE FOR VARIOUS NANOPARTICLE CARRIERS

University of Texas at Arlington, August 2017 – December 2017 Researched the drug release profile of a hydrophilic drug in three carriers i.e low molecular weight PLGA, drug trapped in a hydrogel and drug trapped in a nanoparticle hydrogel composite. The drug used for all three carriers was BSA and drug release profile was studied. After comparing all three profiles, it was established that to achieve a slow and sustained release and to avoid burst release, a nanoparticle hydrogel composite would be the best choice. ULTRASOUND THERMAL STRAIN IMAGING USING 3D PRINTING University of Texas at Arlington, August 2016 – December 2016 Introduced a technique for detection of lipids in plaque. In lipids, as temperature changes, the RF echoes shift in time of flight which produces apparent strain and this was exploited to identify lipid bearing tissue using Ultrasound Thermal Strain Imaging. CALMING EFFECTS OF BINAURAL BEATS ON EEG

University of Texas at Arlington, August 2016 – December 2016 Studied EEG under the effect of therapeutic music. Different subjects were attached to EEG electrodes and alpha, beta, theta waves were studied under the effect of Binaural beats, which claim to induce calming effects. ANOVA was performed on the left and right hemispheres of the three brain waves and results proved that the Binaural beats did induce calming effects on the subject. MALARIA DETECTION USING IMAGE PROCESSING TECHNIQUES University of Mumbai, January 2016 – May 2016

This project was proposed to reduce the manpower needed in malaria inflicted areas as the software can start analysis immediately unlike technicians who need to gain experience for efficient results. Image processing techniques using MATLAB were implemented in detecting the malarial virus based on size and color.

Results were validated against manual observations and error reported was very less when compared. PROFESSIONAL SUMMARY & SKILLSETS

Over 1-year experience working for medical device industry as a Biomedical Engineer. Bachelors’ and Masters’ degree in Biomedical Engineering. Lean Six Sigma Green Belt Certification.

Six Sigma methodologies: DMAIC, 5S, Lean, Root Cause Analysis, Design of Six Sigma, Poka-yoke, Kaizen, Kanban, Process Control Charts, Fishbone Diagrams, Pareto Charts, Gage R &R. Working knowledge of medical device requirements and standards such as FDA regulations, ISO13485, ISO 14971, 21 CFR parts 820, 510k, FMEA, PFMEA, cGMP, CAPA, Design of Experiment (DOE), Product Design and Development, NCR’s, Design controls.

Software: Adobe Illustrator, Photoshop, MS Office (MS Word & Excel), Unix(MacOS), AutoCAD, SolidWorks, R Programming, SAS, MATLAB, Simulink, Solid works

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