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Biomedical Engineer

New Haven, CT
September 17, 2018

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Sudeep Kumar Vakiti

** ***** ***, *** *****, CT-*6511


Systems Test Engineer, Medtronic (Infotree), North Haven, CT January 2018 - Present Minimally Invasive Therapies (MITG) - Surgical Innovations Group – R&D System Test Team

● Develop test methods and fixtures to assist in subsystem integration and validate design changes against System Requirements (SRs) for class-II medical device

● Train test team members on test methods and operation of complex electromechanical equipment like Instron, CMM, LabView DAQ, Autoclave, Autowash and universal programmable robots.

● Capture new requirements in Agile and modify existing ones based on the results of preclinical testing and Design Verification activities on the Robotic Assisted Surgery system

● Perform Engineering testing against the SRs - streamline testing activities based on the Engineering Analysis reports using statistical analysis tools like Gage R&R- Minitab. Biomedical Engineer, Zimmer Biomet, Warsaw, IN July 2017 – January 2018

● Supported sterile packaging team by testing packages and performing validations for sealers

-Instron Tensile strength, sterile barrier, transport simulation, vacuum and specimen integrity testing.

● Determined optimized parameters for material and sample size by analyzing test data in Minitab and investigate test failures from evaluation Design of Experiments (DOE) reports.

● Prepared and assembled laboratory equipment to comply with cGMP and GLP specification recommended for FDA class-II device quality assurance.

● Performed Equipment Qualification and tracked calibration to comply with ISO-13485 QMS.

● Reviewed documentation and reports as part of OQ, PQ and IQ before submission to Quality Engineer

● Provided technical support as and when needed- troubleshoot the electromechanical test system Biomedical Engineer, University of Florida, Gainesville, FL May 2016 – June 2017

● Developed LabVIEW- Data Acquisition (DAQ) driver to control magnetic force bioreactor for conditioning magnetic nanoparticles for stem cell activation and drug targeting.

● Designed and 3D printed Magnetic filters using Solidworks to simulate EM field effects.

● Assembled and calibrated functional setup of magnetic force bioreactor- laboratory equipment installation and training responsibilities

Hardware Engineer, Apollo Computing Laboratories (P) Ltd, Hyderabad, India July 2014 - July 2015

● Coordinated design of aviation electronic equipment for DO-254 Certification

- Recorded IQ, OQ, PQ reports and drafted SOPs- Compile Acceptance and Quality Test Results.

-Supported onsite installation and training for Harness Tester/ Validation test jig

● Revised the Verification and Validation protocols for MIL-Grade Products

- Updated SOPs for Thermal Analysis, Power WC estimation, Environmental and Mechanical Load tests

- Developed RT-Validation Test Jig for automated testing of module- reduced cycle from 30 to 18 hours for Signal Integrity testing for cable assemblies and noise shielding tests

● Document lifecycle artifacts for ISO 9001:2008 QMS audits

- Performed Failure Effects and Root Cause Analysis while maintaining traceability, design control

- Adapted risk management tools like Derating Analysis and FMEA for predicting failure rates

- Improved MTBF (mean time between failures) from 8000 hours to 12000 hours. PROJECTS

Resonant Magnetostrictive MEMS Sensors January 2016 – April 2016

● Investigated the non-linear frequency response of magnetic field MEG sensor using Solidworks-FEA and COMSOL simulation -Acquired prediction curves by using Statistical Analysis models in Minitab Clinical Preceptorship, BME Proposal August 2016 – December 2016

● Developed a strategy to improve neovascularization and reduce non-unions in bone plate surgery patients using HPMC Hydrogels- prototype model with FDA Class-II device -510k regulatory pathway EDUCATION

Master of Science in Biomedical Engineering May 2017 University of Florida (UF), Gainesville, FL

Bachelor of Engineering in Electrical and Electronics Engineering June 2014 Birla Institute of Technology and Science (BITS)-Pilani, Hyderabad Campus, India CERTIFICATIONS

National Instruments LabVIEW Certified Associate Developer [CLAD] April 2016 – April 2018 Programming Skills: C, Java, Python

Tools: Microsoft Office (Word, Excel, PowerPoint, Visio, Project), Agile, MATLAB, Minitab, Solidworks, LabVIEW, Altium, FMEA.

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