Start date: ASAP
Duration: Open-ended / Ad-hoc
Hours per week: As needed
Our Medical Device client is currently seeking a Human Factors Specialist to assist with a bird’s eye overview on the HFE activities including documentation review and user testing ran by groups that also needs to be reviewed. The essential human factors elements and documentation has been completed, in which the client would like to bring in an experienced resource to ensure the HFE activities are fully prepped to ensure the human factors documentation and activities have been formally met. The selected resource will provide technical expertise, guidance, and input regarding human factors processes, principles and overall analyses of where current efforts stand, mitigate any risks and identify any gaps.
Prior experience developing regulated class II medical devices, including performing human factors analyses, design and executing formative summative human factors usability studies is required (8+ years preferred or a proven project-completed history with relative job scope experience). Comprehensive knowledge of HFE principles, applicable IEC & ISO standards, and a demonstrated work history of assisting medical device clients in the guidance & development of class II medical devices is required. The medical device is considered a 510k Medical Device similar to the DonJoy Iceman Cold Therapy or Polar Cube Water Circulating Pads (expertise with relevant product is highly preferred).
Human Factors Specialist (233783) Remote