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Current version of ZOLL's Wearable Cardioverter Defibrillator

ZOLL Medical: LifeVest

Research & Development Team - Human Factors Engineering

Human Factors Engineer Co-op

From June 2022 through August 2023, I served as a Full Time Human Factors Engineering Co-op for ZOLL LifeVest. I joined ZOLL during their FDA Verification and Validation process for the newest iteration of the LifeVest system for both hardware and software. I have aided with the HFE Validation submission to the FDA and provided project management support to the medical affairs team for their clinical study validation efforts.​

 

For the next 18 months, I conducted heuristic, formative, and summative usability and wear testing with internal and external participants to evaluate prototypes of the next-generation LifeVest System.

My Contributions

Documentation

And

Compliance

  • Task and Hazard Analysis: Created and documented task and hazard analyses, risk mitigation plans, root cause investigations, and study protocols. This helped reduce user errors and ensured the safety and reliability of medical devices.

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  • Survey Methodologies: Developed and applied both qualitative and quantitative survey methods to improve user engagement. Designed a feedback survey that offered valuable insights, leading to ongoing improvements in product design.

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Skills Learned

My Roles

During my time at ZOLL, I worked as

  • Project Manager

    • for the Clinical Medical Affairs division for clinical FDA validation studies

    • for Support Mode Software Development efforts 

  • During my time, I had the opportunity to pass four FDA verification in both hardware and software for the wearable cardiovascular medical device. I was able to lead my peers on risk mitigation. I have aided with the HFE Validation submission to the FDA and provided project management support to the medical affairs team for their clinical study validation efforts.

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I worked with other co-ops and full-time staff on Human Factors validation for this newer version of the system. I was involved in study design and execution, data analysis, risk management and mitigation, documentation, and project management for both the Human Factors and Clinical Medical Affairs team.

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- FDA Guidance for Human Factors (2016)  - FDA Supplemental Guidance for Human Factors Information in Marketing Submissions (2022) - ISO 62366-1/62366-2 - ISO 14971 - Task & Hazard Analysis - Usability Engineering Procedure  - Use Specification - User Interface Specification - Patient/Clinician Manual

Regulatory documents referenced:

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