Human Factors Specialist (233783) Remote

Engineering Services | Healthcare IT | Life Sciences & Technology

Start date: ASAP

Location: Remote-based

Duration: Open-ended / Ad-hoc

Hours per week: As needed

Job description:

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


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
Remote, United States

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