Senior Human Factors Engineer - Medical Device UX

Artidis Ag; Houston (TX); On-site; USD 120,000 - 160,000; Full time

Job summary

Artidis is seeking a Senior Human Factors Engineer to own usability engineering for our medical device and connected platform. You will define user needs, create UX requirements, and manage use-related risk across the product lifecycle, collaborating with Design, Systems, QA, Clinical Operations, and Regulatory Affairs to ensure safe, intuitive solutions.

The role requires 5+ years in medical device HF, experience with radiology/oncology workflows, and on-site work in Houston.

Qualifications

• Bachelor's or master's degree in Human Factors Engineering, Ergonomics, Engineering Psychology, Biomedical Engineering, Cognitive Psychology, Industrial Engineering, UX, or related discipline.
• 5+ years of human factors/usability engineering experience in the medical device field.
• Experience with radiology/oncology clinical workflows is a plus.
• Knowledge of IEC 62366-1, FDA Human Factors guidance, and ISO 14971.
• Formative and summative usability study protocol authoring and reporting.

Responsibilities

• Lead end-to-end Usability Engineering File (UEF) per ANSI/AAMI HE75, IEC 62366-1, FDA guidance, and 21 CFR 820.30.
• Define and implement human factors strategy aligned with product development milestones.
• Plan, schedule, and execute formative and summative usability studies across the product lifecycle.
• Design usability test protocols, recruit participants, run sessions and author study reports.
• Lead URRA and integrate findings into risk management processes.
• Collaborate with cross-functional teams to ensure user needs reflect clinical workflows.
• Ensure labeling and onboarding materials minimize use-related risk and support safe operation.

Skills

Human factors engineering

Usability testing

Regulatory submissions

Clinical workflows

Education

Bachelor's or Master's in a relevant field

Tools

Codebeamer

Job description

Artidis is seeking a Senior Human Factors Engineer to own usability engineering for our medical device and connected platform. You will define user needs, create UX requirements, and manage use-related risk across the product lifecycle, collaborating with Design, Systems, QA, Clinical Operations, and Regulatory Affairs to ensure safe, intuitive solutions.

The role requires 5+ years in medical device HF, experience with radiology/oncology workflows, and on-site work in Houston.