SAVINA STEPHANIE SALDANHA

CSSGB (Institute of Industrial and Systems Engineers), GCP,GMP,SOP,CAPA

ac0kt8@r.postjobfree.com 469-***-**** <https://www.linkedin.com/in/savina-saldanha> SUMMARY

Masters graduate in Biomedical Engineering with work experience in R&D and Operations in the development of new products and manufacturing processes focusing on interventional cardiology and mammography. Aspiring to build a career in a growing organization where I can use my time management and technical skills to deliver results. I work well in teams as a key functional core team member.

WORK EXPERIENCE

1. Systems Engineer, GE Healthcare (sponsor ATC, Kuwait) (Jan’13-Jun’15)

Worked on Stent and Delivery system production processes and assisted in Gamma-knife, SPECT, SPECTCT and PETCT installation along with brachytherapy with 90% uptime, oncology management systems 100% uptime.

Developed testable system level requirements and prepared reports of clinical data by being an Integral part of a team involved in generating prototype models to evaluate new design concepts alongside component level engineering verification and validation testing, assisted with quality systems investigators and provided field support.

Coordinated product evaluation with surgeons to enhance the product satisfaction rate

Worked on improving the efficiency of Microelectronics pertaining to Pacemakers, Linear accelerators, Fetal monitors, Blood transfusion machines, surgical needles etc. in the Design workshop.

Provided Post market, technical and surgical support as necessary alongside performing risk assessment, fault tree analysis. 2. Diagnostic Imaging Intern, Dasman Diabetes Institute, Kuwait (Aug’14-Dec ‘14)

Attained knowledge on PACS, RIS and HIS during the “Student Ambassador Program” internship.

Audited Quality Assurance and Quality Control procedures using SOP, GMP, CAPA and GCP knowledge 3. Research Assistant, Dasman Diabetes Institute, Kuwait (Aug’14-Dec’14)

Worked on a research project pertaining to non-invasive intravenous drug delivery modules mainly for diabetic patients, sponsored by the Radiologists at Dasman Diabetes Institute (Kuwait), which is a Canadian accredited institution. 4. Graduate research assistant, University of Texas at Arlington (July’16-Present)

Designed and composed case report forms, clinical protocol and statistical plan for IDE trial

Worked on clinical trials on mice to test the influence of 6 types of drugs on an operated limb, conducted statistical analysis to comprehend the pros and cons using software (GLM, Logistic model, Cox model, GEE and Mixed Model) EDUCATION

University of Texas at Arlington, U.S.A (3.4 CGPA) (Aug’15-May’17) M.S. in Biomedical Engineering with “Thesis substitute specializing in Medical Imaging” Manipal Institute of Technology, India (June’10-June’14) Bachelors of Technology, Bioengineering, (7.2 CGPA on scale of 10.0) SKILLS

Technical and Programming languages: Matlab, Labview, Virtualwire, Keil μvision, TurboC++, Programming in Microprocessors, Arduino UNO, R Programming software, Solidworks, Operations research,(CSSGB) Six Sigma Green Belt Certified (Institute Of Industrial and Systems Engineers), Statistical modelling tools QUALIFICATIONS

Enhanced the functioning of Diagnostic imaging dept. by reducing the dependence on redundant procedures

Implemented new and less time-consuming calibration procedures and Acquired knowledge on product design for manufacturability, inspection and optimum cost.

Generated comprehensive protocols for testing/analyzing the product and design assurance documentation for the quality control purposes and experience in an FDA regulated environment with knowledge in QSR and ISO. PROJECT WORK

Non-invasive Carbon dioxide sensor for neonates (Virtualwire,Liquid Crystal Display, Arduino UNO) Construction involved a 433 MHz Transmitter and communicated wirelessly in order to produce the values on an LCD module in mmHg, final o/p was obtained on graph with breathing pattern plotted against time.

MRI Research Project

Hands on experience while working on a comparative study pertaining to “IDEAL (Dixon Technique) and fat suppression technique in MRI” conducted by exploiting the differences in resonance frequencies between fat and water-bound protons which involved changing the attributes like angle and exposure time to produce optimum effect without affecting the tissue contrast thus resulting in Dosage Reduction in MRI