Human Factors Expert F/M
Core
Lead human factors engineering strategy, design device user interfaces, and conduct usability assessments to ensure regulatory approval and safety for drug delivery systems and medical devices.
Role type
Senior Human Factors Engineer (Medical Devices)
Builds
Usable, safe, and regulatory-compliant drug delivery devices and medical device user interfaces
Domain
Biopharmaceuticals / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Human factors engineering strategy, contextual inquiry research, task and workflow analysis, user needs requirements definition, use-related risk analysis, usability test design and analysis, interview and survey design, regulatory documentation preparation, innovation in HF approaches, mentoring and training
Preferred skills
Pharmaceutical or medical device product development experience, knowledge of medical device regulations and standards
Technologies
None explicitly listed
Responsibilities
Determine and lead human factors engineering strategy for product development projects, Design and conduct contextual inquiry research, Perform task and workflow analyses, Work with System Engineers to develop user needs requirements and user interface specifications, Conduct and evaluate Use-Related Risk Analyses, Design device and system user interfaces and associated instructional materials, Design and conduct usability tests and other usability assessments, Prepare and compile thorough documentation for inclusion in regulatory submissions, Mentors and trains functional colleagues
Seniority
Senior, hands-on IC with mentorship responsibilities
