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Biomedical Engineering, Six Sigma, Technical writing, GMP (FDA)

Location:
Somerville, NJ, 08876
Posted:
September 24, 2016

Contact this candidate

Resume:

K h y a t i P a n d y a

B i o m e d i c a l E n g i n e e r

Address

** ********* ******, *** **,

Somerville, NJ – 08876

Phone

646-***-****

Email

acwq8r@r.postjobfree.com

https://www.linkedin.com/in/khyaticpandya

Objective

Seeking a challenging career as Quality /Product Development Engineer in Medical Devices domain

Abridgement

A focused Biomedical Engineer with experience and interest in Medical Devices – quality, product development, and/or production and testing.

Skilled in sample testing and product design using MTS testing machines, intravascular ultrasound, LabVIEW, AutoCAD and Solidworks.

Training on FDA guidelines for GMP and 510(k).

Knowledge of Quality procedures like ISO 13485 and Six Sigma.

Deftness with Laboratory methods like ELISA, Cell culture, Cryo-preservation and Cell viability assay.

Experience in clinical research and statistics with tools like SPSS and Biopac.

Currently working towards CQT (Quality) and CAPM (Project Management) certification.

A great team player with multi-cultural experience living in USA, Europe and Asia with good time management, reporting and analyzing skills. Work experience

Aug 2015 to May 2016 Biomedical Research Assistant, Toshiba Stroke and Vascular Research Center, NY- USA.

Implemented a model to improve the endoscopic evacuation of intracranial hematoma (ICH) by attaching ultrasound probe.

Product design and simulation using Autocad and Solidworks.

Constructed neurovascular ballistic gel phantoms and used testing machines like intravascular ultrasound and MTS on prototype.

Analyzed research data using Excel and validated the accuracy of the designed model.

Developed research protocol for the process and final reporting as technical research paper.

May 2015 to Oct 2015 Undergraduate Research Assistant, Department of Biomedical Engineering, University at Buffalo NY- USA.

Assisted in the research of PEGDA hydrogels as a functional liver tissue scaffold.

Performed cell culture and used in experimenting and testing processes.

Analyzed the viability of cells by using live / dead cell assays and florescent microscope.

Performed ELISA test to measure the concentration of albumin protein in the liver cells sample.

Measured changes in enzyme activity in 2D by performing mass spectrometry using Cytochrome P450 enzyme assay.

Performed Cryo-preservation technique.

Projects

Placebo Effect of Alcohol on Blood pressure, Heart rate, Reaction time, Fatigue, and Eye movements

The purpose of the project was to observe the effect of alcohol placebo on blood pressure, heart rate, reaction time, fatigue, and eye movements. ECG, BP, EMG, and EOG were done on the subjects to determine the effects. Biopac software was used to record and analyze the experimental results for multiple setup to validate the accuracy of results.

Improving Storage and Inventory Problems of CVS Pharmacy by implementing Six Sigma Rules

The purpose of the project was to apply six sigma principles to improve CVS pharmacy’s daily processes in inventory management. The main objective was to fix the storage and inventory problem of the store by implementing six sigma methods such as DMAIC and 5S process. The results showed factors such as decreased variability in the process and improvement in overall customer service quality.

Evaluating Ergonomics in garment industry

The projects goal was to evaluate the ergonomics and working environment of the Cambodian textile and garment industry workers, which remains primary economic growth pillar for the country. Working conditions were scrutinized by using indirect observational method through the articles, YouTube videos, newspaper citing’s and web images of the workplace.

The continuous use of arm and wrist is exposing workers to musculoskeletal disorder. To identify the risk factors related to ergonomics, Rapid upper limb assessment (RULA) and Rapid entire body assessment (REBA) methods, as well as OSHA ergonomics framework related to sewing was used.

Education

2012 to 2016 Bachelor of Science in Biomedical Engineering, School of Engineering and Applied Science,

University at Buffalo, NY- USA.

2011 to 2012 Bachelor of Commerce in Management,

John Molson School of Business,

Montreal, Canada (Completed 3 semesters).

Additional skills and Certifications

Certifications:

- Laboratory Safety Training, Environment, Health & Safety (EHS)

- IRB Certification (Collaborative Institutional Training Initiative)

- IACUCs (Institutional Animal care and Use Committees)

Professional skills: Training on Project Management and Quality, Courses in Six Sigma and ERP

Software skills: Microsoft Excel with Visual Basic, AutoCAD, Solidworks, MTS TestSuite

(TWS)

Technical skills: ELISA, Cell Culture, Cryo-preservation, Data analyses, Mass Spectrometry

Languages: English, French, Hindi, Gujarati



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