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Malt Strategy
Malt Strategy
Busra YetkinBY

Busra Yetkin

Usability (Human Factors) Engineer

EUR 450/Tag
Heilbronn, DE
3-7 Jahre
Usability Engineering file preparation
Risk analysis
Validation of medical devices
Development of User Interface Requirement and Specifications
Proicient with IEC 62366-1, FDA Human Factors Engineering Guidance

Durchschnittliche Reaktionszeit: 1h

Über Busra

I am a usability engineer focused on developing safe, and user-centered medical devices and healthcare solutions. I have hands-on experience integrating usability engineering into risk management processes, conducting usability studies, and ensuring compliance with MDR and FDA requirements.

  • Türkisch

    Muttersprachlich oder zweisprachig

  • Englisch

    Verhandlungssicher

Vor Ort möglich
Heilbronn (bis zu 50 km), Stuttgart (bis zu 50 km), Frankfurt am Main (bis zu 50 km)

Projekt- und Berufserfahrung

  • Vectura Group,
    Lead Human Factors Engineer
    MEDIZIN
    Juli 2022 - Juni 2024 (1 Jahr und 11 Monate)
    Cambridge, UK
    • Generated usability documents throughout the product lifecycle (including URS, Use Specification, Known Use Problems, Task Analysis, User Interface Specification, etc.) to ensure compliance to the latest HF/usability standards and guidance (IEC 62366, FDA HF Guidance).
    • Prepared Usability Engineering Plan to align usability activities with the device development process
    • Collaborated on the use-related aspects of the risk management process (including Risk Management Plan, uFMEA, Risk Management Report) and led Use-Related Risk Analysis and Benefit-Risk Analysis.
    • Created validation / Usability plans and protocols to cover all URS aspects in the traceability matrix
    • Supervised the formative and summative study executions with external test houses, led the Validation Study Report preparations
    • Reported the results and conclusions of individual usability studies and of the overall usability plan, and communicated these outcomes within project team meetings and design phase reviews
    • Managed usability documentation according to the project governance policy, for the Design History File
    • Applied working knowledge of ISO 14971 Risk Management standard for medical devices, 21CFR820.30, Design Controls, EN ISO 13485.
    Proicient with IEC 62366-1, FDA Human Factors Engineering Guidance Development of User Interface Requirement and Specifications Usability Engineering file preparation Risk analysis
  • ESOGÜ
    Research Assistant
    FORSCHUNG
    März 2017 - Juni 2022 (5 Jahre und 3 Monate)
    Eskişehir, Türkei
    •PhD thesis focused on applying digital human modeling and experimental design to optimize ergonomic risk and user interaction in complex human–robot environments
    •Conducted usability evaluation using think-aloud method and focus groups with more than 20 operators to implement an effective human-robot collaboration
    •Performed contextual inquiry, NASA-TLX and direct measurement methods to analyze operator physical and mental workload in laboratory environment
    •Gained a strong foundation for ergonomics and human factors through many classes and projects
    statistical analysis experimental design human performance evaluation digital human modelling risk based ergonomic assessment
  • GE Aerospace-TEI
    Planning Engineer
    Januar 2014 - Januar 2017 (3 Jahre)
    • • Planned and coordinated operational schedules to ensure project timeline adherence. Collaborated with cross-functional teams to optimize resource allocation and efficiency.

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Ausbildung und Abschlüsse

  • PhD
    Eskisehir Osmangazi University
    2024
    - Doctorate at Human Machine Systems - Concentrations: Human Machine Interaction, Human Factors, User-centered design, Cognitive Ergonomics - Thesis: Application of digital human modeling and experimental design for ergonomicrisk optimization in a human-robot collaboration workstation
  • MSc
    ESOGU
    2019
    - Concentrations: Physical ergonomic Risk Factors, Multi-Objective Modelling - Thesis: Solution of Ergonomic Assembly Line Balancing Problem with Conic Scalarization and REBA Methods
Ausbildung und Abschlüsse von Busra ansehen

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