Ebony Daniels Sanon

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Quality Engineer

Ebony began her career as a mechanical design engineer in the automotive and aerospace industries.  She later became a biomedical engineer with the FDA CDRH/Office of Compliance/Division of Enforcement where she evaluated 510(k)’s, PMA Supplements, Recalls, Establishment Inspection Reports and designed a Company Compliance Profile Reporting system.  Her past work includes filter characterization studies for the TRMM NASA satellite, the assessment of endothelial cell behavior and surface treatments on the biocompatibility and corrosion of titanium biodegradable alloys for orthopedic applications, hazard analysis of endoscopic devices, IQ/OQ/PQ for implantable surgical mesh and metallic knee/hip implants and design control traceability activities for in-vitro diagnostic immunoassays.

 

EXPERIENCE…
  • Designed and developed a company compliance reporting firmware for the FDA Division of Enforcement that allows highly distracted personnel to gather overall company compliance information quickly, efficiently and report the analysis with high impact.
  • Reviewed and processed Premarket Approval (PMA) Supplements for manufacturing method and process changes.
  • Identified 30-Day Notice deficiencies per 21 CFR 820 and corresponded with firms for correction.
  • Recommended the recall classification of circulatory and vascular devices and assigned the appropriate violation of acts and regulation.
  • Reviewed Establishment Inspection Reports and indicated the appropriate action.
  • Interviewed FDA staff and branch chiefs across divisions for focus group aimed at improving medical device quality versus compliance.
  • Supported medical device quality departments in several companies through process validation efforts within a cross functional team.
  • Generated qualification/validation protocols, plans and reports (IQ, OQ, PQ, PPQ and TMV) as well as manufacturing and R&D through optimization of manufacturing procedures, pFMEA, dFMEA and drawings.
  • Provided risk-based clinical assessment support by generating risk management plans and reports and hazard analysis for Class I and II endosurgery medical devices.
  • Designed and manufactured electrochemical cell apparatus for the study of implantable metallic alloys.
  • Performed filter characterization for visible and infrared remote sensing instrumentation in the biospherics laboratory division and calibrations engineering lab.
  • Established effective channels of technical and non-technical communication between design, manufacturing and marketing departments. Identified new areas of marketability and generated leads for the automotive, heavy vehicle, appliances and HVAC industries.
  • Generated quarterly forecasts and assisted in monitoring manufacturing lines.
  • Performed reliability tests through the use of computerized simulations and delivered high quality product to customers. Performed design modification to comply with customer specifications.
  • Designed and manufactured an automotive wheel bearing setting gauge to be used as a demonstration model.  Conducted tests and research on magnetic speed sensors. Implemented a new method of design which drastically increased product efficiency and selection by two fold.
POSITIONS HELD…
  • Quality Engineer – BioTeknica, Inc.
  • Biomedical Engineer – Food & Drug Administration, (FDA) Office of Compliance
  • Validation, Quality Engineer – Goode Consulting, Inc.
  • Graduate Fellow – Florida International University
  • Engineering Co-op – NASA, Goddard Space & Flight Center
  • Field Sales Engineer – Texas Instruments, Inc.
  • Design Engineer – The Timken Company
EDUCATION…
  • M.S., Biomedical Engineering – Florida International University
  • B.S., Mechanical Engineering – Howard University
PROFESSIONAL AFFILIATIONS…
  • National Society of Black Engineers
  • Society of Women Engineers
  • BioFlorida (Leadership & Planning Committee, South East Chapter)