Human Factor Engineer

Job Purpose

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.

Duties and Responsibilities

User Needs & Requirements Definition

• 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.

Usability Engineering & Study Execution

• 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 interface and workflow decisions for ARTIDISNET and connected measurement systems.
• Evaluate user interaction with ARTIDISNET, connected software systems, and clinician-facing outputs to ensure safe, effective, and intuitive operation.

Cross-Functional Ownership & Follow-Up

• Drive closure of all human factors activities and action items across design reviews, development phases, verification and validation activities, regulatory submissions, and post-market activities, escalating risks to timelines when necessary.
• Author Human Factors Engineering Reports, URRAs, study protocols, study reports, and human factors sections of regulatory submissions including De Novo, 510(k), IVDR, and other applicable submissions.
• Respond to FDA, notified body, and other regulatory authority questions related to usability engineering and human factors activities.
• Collaborate with Design, Systems Engineering, Data Science, Clinical Operations, Quality Assurance, and Regulatory Affairs to ensure usability considerations are incorporated into product design decisions.
• Ensure labeling, IFUs, software messaging, onboarding workflows, and training materials minimize use-related risk and support safe and effective operation.
• Present human factors strategy, risks, study results, and recommendations at cross-functional design reviews and decision-gate meetings.
• Serve as the Human Factors Engineering subject matter expert within the organization and influence cross-functional stakeholders to implement user-centered design principles.
• Maintain close collaboration with Quality to monitor complaint trends, use-related events, customer feedback, and field observations, ensuring findings are incorporated into usability engineering and risk management documentation.

Qualifications

• Bachelor's or master's degree in Human Factors Engineering, Ergonomics, Engineering Psychology, Biomedical Engineering, Cognitive Psychology, Industrial Engineering, User Experience (UX), or a related discipline.
• 5+ years of human factors / usability engineering experience in the medical device field. Prior imaging, diagnostic, or oncology device experience preferred. No AFM background required.
• Direct experience working with or designing for radiology and/or oncology clinical workflows, e.g., imaging suites, pathology, tumor boards, or oncology treatment planning is an advantage.
• Working knowledge of IEC 62366-1, FDA Human Factors and Usability Engineering guidance, and ISO 14971.
• Demonstrated experience planning and conducting formative and summative usability studies, including protocol authoring and final report writing.
• Familiarity with design control processes under 21 CFR 820.30 and ISO 13485.
• Comfort engaging directly with radiologists, oncologists, pathologists, and other clinical users to elicit and validate user needs.
• Strong written and verbal communication skills; comfortable presenting findings to cross-functional and regulatory audiences.
• Ability to work on-site in Houston with periodic travel.

Desired Qualifications:

• Prior clinical, imaging, or oncology diagnostic device experience (radiology, pathology, oncology, or interventional imaging platforms).
• Experience authoring or contributing to De Novo or 510(k) submissions.
• Familiarity with Codebeamer or similar requirements/quality management systems.
• Experience with EMR/HL7-FHIR-connected clinical software workflows.
• Certified Human Factors Professional (CHFP) or equivalent credential.

Working Conditions

The environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team, and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance.