Saqib Alavi

ac8j3m@r.postjobfree.com 901-***-**** https://www.linkedin.com/in/saqib-alavi-34b607129/

Seeking an engineering role in the medical device industry to grow into challenging levels of corporate responsibility.

PROFESSIONAL SUMMARY

MS Biomedical Engineer specialized in Quality assurance of medical equipment, Lean Six Sigma Green Belt Certified.

Working knowledge with US FDA current Good Manufacturing Practices(cGMP’s), ISO 13485, ISO 14971.

Initiation, documentation and assisting execution for IQ, OQ, and PQ activities.

510k submissions and 21 CFR 820 guidelines on Validation, Design, Risk Management.

Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis and process mapping.

Software skills- MATLAB, SolidWorks, Minitab, SAS, MS Word, Excel and PowerPoint Visual Basic.

PROFESSIONAL WORK EXPERIENCE

Biomedical Engineer, Omega Hospital August 2015-July 2016

Performed preventive maintenance inspection, electrical safety testing and corrected problems encountered in Class 2 Class 3 medical devices, accomplishing Standard Operating Procedure.

Evaluated QSR along with safety, performance of Biomedical Equipment within the hospital’s responsibility.

Significantly involved in inspections by regulatory agencies performing clinical audits as needed.

Maintained product quality and integrity through evaluation and disposition of non-conforming materials.

Operations Co-op Engineer, Stellar Meditech January 2015-July 2015

Applied problem-solving tools such as fishbone, Pareto, Process and Test Method Validation.

Delivered Bill of Materials Cost, investment and weight for responsible component and system set BOM management.

Assisted in performing Root Cause Analysis to identify effective Corrective actions CAPA and process improvement.

Implemented DFSS including DMAIC, 5s, Kaizen, SIPOC, Value stream mapping minimizing Delays, Cost of Delays, overproduction, unutilized talent and errors.

PROJECT EXPERIENCE

Extended Kalman Filter Optimization August 2017-Dec 2017

Using MATLAB Simulink, optimized an extended Kalman filter for non- linear dynamics.

Optimized the filter so a control system simulation can run when setting different initial conditions.

Comparing Raw and Filtered ECG August 2017-Dec 2017

Compared Raw and Filtered ECG from subject readings and analyzed the heart beats per minute.

Obtained and plotted graphs using MATLAB, showing any irregularities in the heart beats.

Drug Release Study for various nanoparticle carriers August 2017-Dec 2017

Drugs were release in hydrophobic and hydrophilic carriers and monitored.

Proved that composites of nanoparticles and hydrogels provide sustain drug release in comparison to individual carriers.

Calming effects of binaural EEG, University of Texas Aug 2016 – Dec 2016

Applied Analysis of Variance (ANOVA) technique to evaluate brainwaves in the left and right hemispheres using EEG. Variations in the frequency and amplitude of brainwaves were observed localizing activated regions of brain.

Measured the effects of calming binaural beats on brains neural activity.

Blood Pressure Monitoring Device, Manipal University Jan 2015 – May 2015

Monitored blood pressure using cuff on a finger and signal was detected using IR LED.

Implemented setup design helping patient record the pressure by himself. Automated the system furthering patient’s ease. Programmed using Arduino micro controller.

EDUCATION

University of Texas, USA Aug 2016-May 2018 Master of Science in Bioengineering CGPA 3.78

Specialization: Quality Assurance, Digital Signal Processing, Bio-Instrumentation. Relevant Coursework: Tissue Ultrasound Imaging, Lab Principles, Statistical Methods, Medical Imaging, System ID and estimation, Process Control in Biotechnology.

Manipal University, India March 2011-July 2015

Bachelor of Technology in Biomedical Engineering

Bachelor of Science in Biomedical Engineering CGPA 3.0