Devyani Nath Email & Phone Number

New York, Ny, Us

Newark, New Jersey, United States

1. Lab Manager of the Biomaterials Laboratory at the Department of Restorative Dentistry.2. Execute statistical data analyses on biological data for clinical evaluations using SAS and SPSS.3. Conduct specialized technical research and development (R&D) in Biomaterials Lab. ▪ Designed an alternative method to intraoral 3D scanners to render 3D models using 2D images with Autodesk Recap. ▪ Led product development and testing of an electromagnetic toothbrush developed in the Biomaterials lab, which also has a US patent. ▪ Conducted mechanical testing on human dentin in diabetic and non-diabetic patients to study the effect of diabetes on oral hard tissue. ▪ Assisted in testing a Class II expandable dental sealer in accordance with ISO 10993 and initiating the 510(k) process. 4. Assists in the establishment of performance standards & selection of methodology & instrumentation. 5. Edit & revise material for the submission of manuscripts, grants, progress reports, and journals.

Newark, New Jersey, United States

Warsaw, Indiana, United States

1. Responsible for the conformation of Class I, Ir & IIa instruments to the latest standards, as part of the EU MDR project.2. Executed Design Controls & analyzed Design Inputs, Regulatory Inputs & Product Specs. Planned, reviewed & approved manufacturing change requests.3. Reviewed Risk Management files & Critical to Quality (CtQ) parameters as part of the latest General Safety Performance Requirements (GSPRs). 4. Liaised cross-functionally with Development, Regulatory Affairs, Research, & Manufacturing plants in different countries. 5. Reviewed Lifetime Assessment & BSA reports, INST forms on CMS, utilized the Product Development Platform (Cognition Cockpit) to organize and update Design History Files (DHF). 6. Worked with QMS & Document Management System (SharePoint) to manage & track electronic documents. 7. Assessed existing FMEA's, verification reports, device prints, and updated any non-confirming documents to comply with EU MDR standards.

Warsaw, Indiana

1. Conducted gap analysis on existing Instructions-For-Use (IFU) docs to ensure conformation with the latest FDA standards.2. Reviewed proposed labeling ensured compliance and prepared new & revised existing IFUs for implants, instruments & kits. 3. Wrote package RIAs, MDRAFs & FNs and routed them through change management system (CMS).4. Utilized Cognition Vault (electronic DHF system) to verify the accuracy of sterilization/validation & Overall Risk-Benefit Analysis (ORBA). 5. Inspected surgical techniques & 510(k)s to technically comprehend the device and validate information present in the IFU.6. Initiated and compiled Technical Files to ensure conformance and compliance with governing directives, standards, and company procedures.

Buffalo/Niagara, New York Area

 Fabricated a wearable using Arduino micro-controller (ATmega328) and Adafruit RGB sensor (TCS34725) that records light wavelengths the eye is exposed to, to establish co-variance between sleep patterns and light Designed multiple hardware prototypes, used MATLAB to compare test results with Ocean Optics spectrometer readings to choose the most optimum hardware increasing device reliability to 100% Designed PCB using NI Ultiboard and nonproprietary semiconductor devices reducing device cost by 80%; reduced device size by 30% improving aesthetics and wearability Built a prototype for the device and successfully tested it in various lighting conditions

 Designed and schematically simulated a two stage operational amplifier on CADENCE virtuoso, used MATLAB and MOSEK to optimize area of the circuit

 Designed and fabricated a Bio MEMS device using AutoCAD and photolithography to separate Mitochondria from the other cell organelles, carried out quality assurance tests and optimization to increase efficacy to 95%  Designed a mixer circuit that increased the efficiency of the device by 50%

Chennai Area, India

Assessed bio-medical instruments in the radiology and cardiology department.Tested, assessed and verified risks of equipment usage on patients

 Implemented a microcontroller CC3200 driven wireless router to establish communication between two cloud systems using C and TCP/IP; gained in-depth knowledge 10+ networking protocols

Tiruchchirappalli Area, India

 Developed and tested a library management system using C and data structures; implemented algorithms to check-out and check-in books and save status to file

 Designed a sensor-less motor circuit using MATLAB Simulink, defined a novel way to control the motor using line voltage

 Designed a servo motor circuit using PSpice simulator, used COM09939 potentiometer to ensure accurate angular position, velocity, and acceleration control

Bengaluru Area, India

 Led a team of 5 software engineers to develop software product that translates coursework to different audio dialects Liaised with MNCs and NGOs to collect user requirements and create partnered awareness programs

Master Of Science - Ms, Bioengineering And Biomedical Engineering, 3.8

Activities and Societies: BRIDGES international, Global CINEMAspectives

Bachelor Of Technology (Btech), Electrical And Electronics Engineering, 3.6

Activities and Societies: Pragyan ( International techno managerial organisation)