Blaze B

Experience

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  Alpha Analytical

  Jan 2013 - Mar 2015

  Test Engineer

  Directed projects to qualify automated medical equipment before being used formal testing from set-up through data interpretation and reporting. Compiled data and prepared reports on system testing on functionality and requirements of hardware, firmware, and software. Led all activities for equipment validation and calibration with method-specific QC requirements following customer and manufacturer protocols.

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  PHILIPS MEDSIZE

  Apr 2015 - May 2017

  QA Analyst III

  Member of Product Development team served as design analyst for electromechanical injector device to detect patient sugar level Class II Drug Delivery device. Performed service record review to ensure quality records, identify potential FDA reportable events, and Business Unit follow-up and escalation. Supported Product Development team by reviewing all requirements and verifying conformance to existing regulations and standard procedures. Generated actionable quality data for product quality trends and improvement. Assisted in handling and tracking of CAPAs, supporting Quality Systems Manager and Engineers in conducting CAPA reviews. Managed and analyzed Graphic User Interface requirements for software, defined each item, and created strategies for smooth flow of test protocols. Verified process control activities and reported deficiencies found. Show less

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  Boston Scientific

  May 2017 - Aug 2018

  Quality Engineer

  Supported ultrasound imaging system with responsibility for leading all aspects of quality assurance in design and production of iLAB Ultrasound Image system version 2.7. Designed and implemented tests effectively and efficiently monitoring the quality of Class II medical device in each stage of development and production process, adhering to strict guidelines for quality and risk in line with government regulations. After test completion, provided feedback to design engineers on methods to improve quality and meet product specifications. As part of Post Market Surveillance Urology division, supported CAPA (Corrective Action Preventive Action) activities for global reports on devices such as Lithovue Lithovue Ureterocope, Flexiva laser and Dakota used by physicians to treat kidney stones. Initiated standards and methods for inspection, testing, and evaluation, recreated Show less

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  Abbott

  Aug 2018 - Dec 2022

  System Validation Engineer

  Support all quality engineering activities for Intravascular Imaging system(OCT) lifecycle from concept to commercialization to treat cardiovascular diseases. Develop validation and verification test protocols based on software and hardware requirements following company's SOPs / DOPs based on FDA’s QSR 21CFR820, IEC-62304, 13485, and 14971. Actively participate in design for quality and manufacturing requirements, process / technology development, product verification / validation, and applicable documentation. Develop, modify, apply, and maintain quality standards and generated protocols and reports in support of the V&V team. Verify and validate Optical Coherence Tomography system software (IVUS-Aptivue) and the next generation hardware solution, a Class II medical device with software including AI / ML (Artificial Intelligence / Machine Learning) based technologies applied to identification of calcification of arterial walls. Perform Root Cause Analysis, problem resolution, and final verification for field and clinical issues. Show less

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  BD

  Jan 2023 - Mar 2024

  Product Security Engineer