Engineer Medical Device

PRATIK VAIDYA

**** ******** ******, ****** **** MN 55112

*********@*****.*** • 216-***-****

EDUCATION

Cleveland State University, Fenn College of Engineering Cleveland, OH

Master of Science in Biomedical Engineering Dec 2012

Shivaji University, Kolhapur Institute of Technology Kolhapur, India

Bachelor of Engineering in Biotechnology July 2009

RELATED COURSEWORK

• Medical Device Design, Biomedical Signal Processing, Biomaterials, Biomechanical Engineering,

Biostatistics, Medical Imaging, Bioprocesses, Biological Thermodynamics, Bioprocess Modeling and

Simulations, Tissue Engineering

SKILLS

Technical: Process Engineering, Technology Transfer, Technical Writing, Medical Device Design, FDA

•

regulations, cGMP

Computer: Rational DOORS tool (IBM), ALM tool (HP), ClearQuest tool (IBM), XCode (iOS), Eclipse

•

(iOS), MATLAB, SQL, Microsoft Office, Team Foundation Server (TFS), Outlook, ImagePro, ImageJ,

Volocity 3D image analysis, Adobe Photoshop

Non-technical: Excellent written and spoken communication, Team management, Troubleshooting and

•

Problem handling

WORK EXPERIENCE

Wipro Technologies Oct 2013 – present

Client: Medtronic, Inc., Minneapolis, MN

Verification Test Engineer

Primary duties include Method Validation of RF Telemetry

• Functionality, performance and integration testing, verifying telemetry device workflow and synchronization

with cardiac implants and mobile user interface (iOS and Android platform), identifying issues against SRS

requirements

• Creating iOS/iPA builds, smoke testing, STUBs and Test Aspect testing

Client: Philips Healthcare, Cleveland, OH

System Verification Engineer

Primary duties included system level testing of new generation CT scanners

• Conducted system and sub-system level testing, module/feature testing. Filed defects, provided quality

feedback to test design engineers/system engineers, participated in TRRs

• Developed test approach, designed tests for specific CT features per the SRS requirements

• Executed Automation scripts for specific features, analyzed automation logs. Provided feedback to

Automation team for fixes.

• Installation of software builds for the CT scanners

Ben Venue Laboratories Cleveland, OH

Chemical Engineer Feb 2013 – Oct 2013

Primary duties include methodically transferring cytotoxic/genotoxic products to a new facility

• Enhanced the development, transfer, and life cycle management of new products and new technologies

• Ensured product readiness and successfully escalated two high priority products to process validation

• Scaled up pilot plant batches to full-scale production batches, provided technical insights and troubleshoot

challenges in manufacturing process

• Executed product remediation involving writing protocols, analyzing data and preparing technical reports,

created manufacturing batch records for engineering and technology transfer batches

Cleveland Clinic Foundation, Lerner Research Institute Cleveland, OH

Research Assistant Jan 2011 – Dec 2012

Project: “Effects of TGF-β1 loaded PLGA nanoparticles on matrix synthesis outcomes in aneurysmal rat aortic

smooth muscle cell cultures”

• Formulated and developed therapeutic loaded nanoparticles

• Characterized nanoparticle properties and therapeutic release profile

• Investigated and analyzed elastogenic effects of therapeutic in cell cultures

• Experienced with cell culture isolation, storage and handling, protein quantification assay, fluorescence and

UV-Vis spectrophotometry, dynamic light scattering, ELISA, western blot, RT-PCR, HPLC, fluorescence

microscopy, confocal microscopy, SEM

Viridis BioPharma Pvt. Ltd. Mumbai, India

Research and Development Associate Jan 2010 – June 2010

Project: Development of wound healing gels

• Formulated thermo-reversible, burn-wound healing gels, analyzed the efficacy of gels in bacterial cultures,

developed SOPs of gel production process

PUBLICATION

L. Venkataraman, B. Sivaraman, P. Vaidya, and A. Ramamurthi. Nanoparticulate Delivery of Agents for Induced

Elastogenesis in 3-Dimensional Collagenous Matrices. J Tissue Eng Regen Med. DOI: 10.1002/term.1889

• My role involved synthesizing polymeric nanoparticles loaded with growth factors that were previously

identified to enhance elastin production in cells isolated from abdominal aortic aneurysmal sites.

PROJECT

Kolhapur Institute of Technology, India June 2008 – May 2009

Project: “Isolation and Characterization of Plasmid and the Gene Responsible for Dye-degradation, Among the Four

Organisms”

• Results established Pseudomonas spp could be utilized industrially to degrade the toxic azo-based dyes, a

component of textile industry effluent

• Experienced with DNA isolation, plasmid DNA curing, SDS-PAGE, protein estimation assays, enzyme

activity assays

• Published results to University

PRESENTATION AND TRAINING

Poster:

•

B. Sivaraman, P. Deb, L. Venkataraman, P. Vaidya, A. Ramamurthi. Parallel approaches to regenerating and

stabilizing elastic matrix for AAA regression. Gordon Conference on Elastin and Elastic Fibers, Biddeford,

ME, July 2011.

Podium:

•

‘Nanorobotics in Nanotechnology’. Pioneer 2K7, Kolhapur, India, in 2007.

Trained at Sangene Institute of Biosciences, Bangalore, on “Enzymology and Protein Chemistry”

•

Contact this candidate