Medical Device

Sheetal Vennamalla

E-mail:*******.**********@*****.*** 512-***-**** Dallas, TX-75252

The University of Texas at Dallas (UTD) May ‘18 (Expecting)

Master of Science, Biomedical Engineering GPA 3.55

Indian Institute of Technology Hyderabad (IITH) May ‘15

Bachelor of Technology, Chemical Engineering GPA 3.10

PROFESSIONAL EXPERIENCE

Quality Engineer Internship, SENSOGRAM TECHNOLOGIES.INC, Dallas, TX Aug ’17 – Dec ’17

●Participated in performance validation including data collection, calibration protocol, and in user interface of device and software app and provided feedback to software development team on glitch found.

●Reported results on firmware comparison using statistical analysis in spreadsheet.

●Assisted in determining product pathway, recommended technical files for EU (CE mark) and in updating device history file (DHF), ISO 14971 risk analysis file and FMEA file, 510k requirements for product.

●Handled inventory for devices, performing calibration on subjects, upgraded BOM for component specifications, and supported in documenting clinical test results.

R&D Internship, SENSOGRAM TECHNOLOGIES.INC, Dallas, TX May ’17 – Aug ‘17

●Researched and built proof of concepts of biosensors for physiological parameters.

●Gathered raw data ECG signals from subjects to determine ECG parameters.

●Achieved HRV parameters (PQRST peak detection, Mean RR, Poincare-plot, LF/HF ratio) using MATLAB.

TEXAS BIOMEDICAL DEVICE CENTER, Dallas, TX Dec ’16 – May ‘17

●Determined pathways for all classes of medical devices in FDA and analyzed needs for medical devices and represented it in the form of flow chart using Visio software tool.

●Prepared support documents such as FMEA, Biocompatibility test, DES etc.

●Approached logically and with good judgment to ensure the appropriate pathways for medical devices market application outcome using IDE, EFS and PMA in FDA.

ACADEMIC EXPERIENCE

Quality Management System Dec’17-present

●Identified medical device requirements to comply with U.S 21 CFR 820 and International standards ISO 13485-2016.

●Performed CAPA case studies to determine root cause analysis (FMEA, Fishbone diagram,5 why and Fault tree) for non-conformity products and complaint files.

●Demonstrated IQ, OQ, PQ for process validation and required statistical tools in Minitab 18.

●Investigated on medical devices inspection (FDA-QSIT) and audits (ISO -IMDRF) and provided checklist.

●Analyzed integration of six sigma DMAIC into CAPA.

●Drafted quality system manual, Sops, process flow map using Visio software.

Medical Device Regulations & Regulatory Strategies Dec’17-present

●Identified regulations required for medical device in FDA-U. S (CFR) database for types of 510k’s, PMA, MDR med-watch, determining regulatory special controls (Labeling, Patient registries, Performance standards).

●Learned to direct through EU-MDD to identify device classification pathway, rules, technical dossiers, QMS).

●Notified upcoming changes in EUDAMED for 2020.

●Navigated through Health Canada-MDR for device classification, rules, QMS requirements including CMDCAS.

●Currently working as a team member to interpret, build, present and defend regulatory strategy for Endoscopic vacuum therapy to gain market entry for U.S.A, Canada and Europe.

TECHNICAL SKILLS

MS Project Management, Microsoft Visio, SharePoint, Excel spreadsheet, MATLAB, Solidworks, Minitab 18, Adobe.

ACADEMIC ACHIEVEMENTS

Integrated Quantification based on Confocal Imaging: Cell Crowding Modulates Heterogeneity in GPCR-Mediated Calcium Oscillation Dec ’14 – Dec ‘15

●Implemented mathematical analysis for calcium oscillation and cell to cell variability for Hela Cells using MATLAB

●Published in 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society [EMBC]

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