Human Factors Engineer

About the role

The Human Factors Engineer will own usability and human‑factors engineering for Artidis' medical device and connected intelligence platform, guiding user‑needs definition, risk management, regulatory submissions and post‑market activities.

Key responsibilities

• Lead elicitation, definition and documentation of user needs through contextual inquiry, task analysis, clinician interviews and site observations.
• Own and maintain the Usability Engineering File (UEF) in compliance with ANSI/AAMI HE75, IEC 62366‑1, FDA guidance and 21 CFR 820.30(c).
• Plan, execute and report formative and summative usability studies, including participant recruitment, protocol design and analysis.
• Conduct use‑related risk analyses (URRA) and integrate findings into ISO 14971 risk management.
• Collaborate with design, systems engineering, quality, clinical operations and regulatory teams to ensure safe, effective and intuitive products.

Required profile

• Bachelor’s or master’s degree in Human Factors Engineering, Ergonomics, Biomedical Engineering, Cognitive Psychology or related field.
• 5+ years of human‑factors/usability engineering experience in medical devices, preferably imaging, diagnostic or oncology platforms.
• Experience working directly with radiologists, oncologists, pathologists or other clinical users.

Required skills

• Knowledge of IEC 62366‑1, FDA Human Factors guidance and ISO 14971.
• Familiarity with design control processes under 21 CFR 820.30 and ISO 13485.
• Experience planning and conducting formative and summative usability studies.
• Ability to author Human Factors Engineering reports, URRAs and regulatory submission sections.
• Exposure to requirements/quality management tools such as Codebeamer (optional).