Senior Human Factors Engineer — Medical Device UX (Houston On-Site)

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

Benefits offered by this job

Competitive salary

Performance bonus

Job summary

Artidis is seeking a Human Factors Engineer to own usability engineering for the medical device and connected platform in Houston. You will define user needs, manage the Usability Engineering File, and lead formative and summative studies in collaboration with Regulatory and QA teams.

You will work closely with Design, Systems Engineering, and Clinical Operations to ensure products are safe, effective, and intuitive for clinicians, with direct impact on regulatory submissions.

Qualifications

• Bachelor's or master's in relevant field; strong human factors background.
• 5+ years in human factors/usability for medical devices.
• Experience with radiology/oncology clinical workflows is a plus.
• Familiarity with IEC 62366-1, FDA HF guidance, ISO 14971, and design controls.
• Proven ability to plan and document formative/summative studies; strong communication.
• On-site in Houston with periodic travel; collaboration across teams.

Responsibilities

• Own the Usability Engineering File per ANSI/HE75, IEC 62366-1, FDA HF guidance.
• Develop HF strategy aligned with product development milestones.
• Plan and execute formative and summative usability activities across lifecycles.
• Design protocols, recruit participants, run sessions, and write reports.
• Lead URRA and integrate findings into risk management processes.
• Collaborate with Design, Systems, QA, Regulatory, and Clinical ops.
• Ensure labeling, onboarding workflows, and software messaging minimize risk.
• Present HF strategy and study results at design reviews and gates.

Skills

Human Factors

Usability Engineering

Regulatory Submissions

Clinical workflows

Education

Bachelor's or Master's in Human Factors/Ergonomics/related

Tools

Codebeamer

IEC 62366-1

FDA 21 CFR 820.30

ISO 14971

Job description

Artidis is seeking a Human Factors Engineer to own usability engineering for the medical device and connected platform in Houston. You will define user needs, manage the Usability Engineering File, and lead formative and summative studies in collaboration with Regulatory and QA teams.

You will work closely with Design, Systems Engineering, and Clinical Operations to ensure products are safe, effective, and intuitive for clinicians, with direct impact on regulatory submissions.