Human Factors Engineer (Contract)

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!

Responsibilities

• Assess current development, design control, quality, and risk management processes to identify where usability engineering activities and artefacts should be embedded.
• Define a lean end-to-end usability engineering process, including activities, inputs/outputs, decision points, roles, responsibilities, and interfaces to risk management and design controls.
• Define the required usability engineering documentation and templates that comply with IEC 62366‑1, ISO 14971, and FDA regulations.
• Conduct and lead formative and summative usability evaluations.
• Maintain and update the Usability Engineering File.
• Conduct formative evaluations to identify and mitigate use‑related issues prior to summative testing.
• Refine critical task analysis, use‑related risk analysis, and hazard‑related use scenarios to ensure appropriate summative coverage.
• Define the summative evaluation scope, including device/product configurations, user groups, use environments, and critical tasks.
• Create the summative evaluation protocol, including acceptance criteria, sample size rationale, recruitment criteria, test scenarios, and success metrics.
• Prepare all required summative testing materials, such as moderator guide, participant materials, observation forms, and other study documentation.
• Conduct the summative evaluation and document the results in a summative evaluation report.
• Assess residual use‑related risks and document conclusions and traceability within the usability engineering file.
• Coaching on how to conduct and document formative and summative evaluations and use‑related risk activities.
• Support the team in building reusable templates, checklists, and playbooks.

Qualifications

• Degree or higher in Human Factors Engineering or a related subject.
• Fluency and confidence in understanding IEC 62366‑1, ISO 14971, and FDA regulations.
• Significant experience conducting human‑factors research with software‑based medical devices 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 the medical device industry.
• Relevant industrial experience commensurate with the 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.

Benefits

• Competitive salary and annual reviews.
• Opportunity to participate in Flo’s performance incentive scheme.
• Paid holiday, sick leave, and female health leave.
• Enhanced parental leave and pay for maternity, paternity, same‑sex and adoptive parents.
• Accelerated professional growth through world‑changing work and learning support.
• In‑person collaboration and work in a hybrid model, with 3 days per week spent in the office.
• 5‑week fully paid sabbatical at 5‑year Floversary.
• Flo Premium for friends & family, plus more health, pension and wellbeing perks.

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