Human Factors Engineer

Flo is seeking an experienced candidate for a contracting role in human factors engineering. The job involves leading usability assessments and managing risk for medical devices, engaging with cross-functional teams, and contributing to regulatory submissions. This role will be embedded within a thriving and enthusiastic UX Research function!

This role is an excellent opportunity for an experienced Human Factors Engineer looking to take the lead on and work independently on a software as a medical device in women’s health.

Your Experience

Must have:

• Degree or higher in Human Factors Engineering, or relevant related subject
• Fluency and confidence understanding IEC 62366‐1, ISO 14971, and FDA regulations
• Significant experience conducting human factors research with software based medical devices that is compliant with IEC 62366‐1, ISO 14971, and FDA regulations
• Experience in creating and maintaining usability documentation to ensure compliance with IEC 62366‐1, ISO 14971, and FDA regulations
• Applied understanding of the product development process
• Applied understanding of medical device industry
• Relevant industrial experience commensurate with requirements of an experienced and independent contractor
• Exceptional attention to detail and precise data handling and analytical skills
• Technical report writing skills
• Exceptional time management skills and an ability to work well under pressure

Nice to have:

• Experience with software as a medical device in the women’s health space
• Experience conducting training on IEC 62366-1 and FDA Human Factors guidance, and practical implementation in a medical device environment

What you'll be doing

You'll be responsible for:

(1) Establishing Usability Engineering at Flo Health

• Assessing current development, design control, quality, and risk management processes to identify where usability engineering activities and artefacts should be embedded
• Defining a lean end-to-end usability engineering process, including activities, inputs/outputs, decision points, roles, responsibilities, and interfaces to risk management and design controls
• Defining the required usability engineering documentation and templates that comply with IEC 62366‐1, ISO 14971, and FDA regulations

(2) Conducting/Leading Formative and Summative Evaluations 

• Maintaining and updating the Usability Engineering File
• Conducting the necessary formative evaluations to identify and mitigate use-related issues prior to summative testing
• Refining the critical task analysis, use-related risk analysis, and hazard-related use scenarios to ensure appropriate summative coverage
• Defining the summative evaluation scope, including device/product configuration(s), user groups, use environments, and critical tasks
• Creating the Summative Evaluation Protocol including acceptance criteria, sample size rationale, recruitment criteria, test scenarios, and success metrics
• Preparing all required summative testing materials, including moderator guide, participant materials, observation forms, and any other study documentation needed for execution
• Conducting the summative evaluation and documenting the results in a Summative Evaluation Report
• Assessing residual use-related risks and documenting conclusions and traceability within the usability engineering file

(3) Upskilling the UXR Team

• Coaching on how to conduct and document formative and summative evaluations and use-related risk activities
• Supporting the team in building reusable templates, checklists, and playbooks

Please note that this is a contractor role. As such, employee benefits do not apply.

#LI-Hybrid #LI-AJ1