Human Factor Engineer

About Artidis

Artidis is a pioneering clinical stage health technology company that aims to set the gold standard in tissue analysis and therapy optimization. By combining its nanotechnology platform for rapid tissue analysis with a holistic data solution, Artidis accelerates drug discovery, tissue engineering, and personalized treatment. Artidis focuses its research and development efforts on solid tumors to enhance responses to chemo, immuno, and cell therapies, driving precision in cancer care.

The Human Factors Engineer holds end-to-end ownership of usability and human factors engineering for the Artidis medical device and connected intelligence platform, from defining user needs and requirements through formative and summative usability studies, use-related risk management, regulatory submissions, and post-market follow-up.

The Human Factors Engineer is the subject matter expert and process owner for Human Factors and Usability Engineering across the Artidis product portfolio. The role owns the Usability Engineering File (UEF) and is responsible for defining user needs, clinical workflows, use specifications, use-related risk controls, and usability validation strategies from concept through commercialization.

Working closely with Design, Systems Engineering, Quality Assurance, Clinical Operations, Product Management, and Regulatory Affairs, this individual ensures products are safe, effective, clinically relevant, and intuitive for intended users while supporting development milestones and regulatory submissions.

• Lead the process of eliciting, defining, and documenting user needs through contextual inquiry, task analysis, clinician interviews, and site observations.
• Serve as the primary owner of user needs, use specifications, task analyses, human factors planning, use-related risk assessments, and usability validation activities throughout the product lifecycle.
• Own translation of user needs into atomic, validatable user need and design requirement statements, ensuring traceability through design inputs, validation, and risk management activities.
• Cross-functional partnering with Systems Engineering, Product Management, Clinical Operations, and Regulatory Affairs to ensure user needs reflect real clinical workflows, intended use, intended use environments, and intended user populations before requirements are finalized.
• Define, maintain, and continuously refine intended use, intended user, use environment, workflow, and task analysis documentation that form the foundation of the Usability Engineering File.

• Own and maintain the Usability Engineering File (UEF) end-to-end, per ANSI/AAMI HE75, IEC 62366-1, FDA Human Factors guidance, and 21 CFR 820.30(c) design controls.
• Develop and maintain the Human Factors Engineering strategy and ensure alignment with product development, verification, validation, and regulatory submission milestones.
• Plan, schedule, and personally follow up on all formative and summative usability activities across the product lifecycle, ensuring no study, protocol, or report stalls without an owner and a closure date.
• Design usability test protocols, recruit and screen representative participants, run sessions, and author formative and summative usability study reports.
• Lead use-related risk analysis (URRA), identifying use errors, critical tasks, and hazard-related use scenarios, and integrate findings into the ISO 14971 risk management process.
• Define critical tasks and validation scope in collaboration with Quality, Risk Management, and Regulatory Affairs.
• Facilitate heuristic evaluations and iterative design walkthroughs with clinical users to shape…