ABOUT THE WORK:

Currently, ZOLL has a Class III (life saving) medical device on the market, in the form of a wearable cardioverter defibrillator (as seen below). For the past 6 years, ZOLL has been working on developing a new version of this system (named the LifeVest 5100). I worked with other co-ops and full-time staff on Human Factors validation for this newer version of the sytem. 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. Additionally, I gained some design experience by participating in a company hackathon in December of 2021 and by leading initial efforts for next-gen designs for the system in the Summer of 2022.

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MY ROLE:

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I served as a full-time Human Factors Engineering co-op for 18 months. I also, for the last 3 months of my co-op, worked as a project manager for the Clinical Medical Affairs division at ZOLL for their clinical FDA validation studies. I now am working in a part-time capacity for the Human Factors team as they finish up their validation efforts.
 

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MY CONTRIBUTIONS:

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• Authored, reviewed, and supported documentation to be provided to the FDA, including, but not limited to: Task and Hazard Analysis, User Interface Specification, Use Specification, Risk Mitigation Analysis, the HFE/UE Report, and many other protocols and reports.

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• Participated in residual risk assessment and mitigation analysis: Worked on data analysis (including root cause) of data that was obtained during studies to ensure that the risk that was presented was acceptable and that there were mitigations in place to divert the risks that were presented in both critical and non-critical tasks.
   

• Participated in a Hackathon: Worked with a multidisciplinary team to develop new ideas for cable management, ECG attachment to the garment, and to increase patient comfort when wearing the system. My specific contributions include a human factors analysis, as well as risk identification and mitigation efforts, of the proposed solutions. Our design one and was then patented by ZOLL.

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• Involved in study prep, execution, and data analysis/report writing for formative and summative testing: I lead some of my own formatives; helped to prep, execute, and write the report for various formatives studies; helped to prep and act as project manager for various summative/validation studies.

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• Acted as a project manager to another group: I had some experience with project management within the HFE team, where I was in charge of coordinating with a third-party research organization that we used to conduct some of our studies and overseeing their work. I also served as a project manager for ZOLL's clinical medical affairs team for their validation efforts to help them coordinate with R&D and make sure that their 300-person study was a success.