Usability Engineer

Key Responsibilities

Usability Engineering & Compliance

• Define and execute the usability engineering approach across product development, including usability engineering plans.
• Conduct use specification development, task analysis, workflow analysis, and scenario creation.
• Identify hazard‑related use scenarios and contribute to usability risk mitigation and usability FMEA.
• Ensure compliance with IEC 62366‑1, FDA Human Factors Guidance, and Philips internal usability processes.
  
  
  

• Perform formative usability studies (concept validation, UI prototype testing, workflow evaluations).
• Plan, conduct, and document summative usability evaluations to support regulatory submissions.
• Conduct contextual inquiries with clinicians, technicians, and other healthcare workers to understand clinical use environments.
  
  
  

• Create HFE documentation including:
• Use specifications
• Task analyses
• Usability risk analyses
• Usability FMEA
• Formative and summative study protocols and reports
• Inputs to the Usability Engineering File
• Compile usability evidence and reports supporting global regulatory submissions.
  
  

• Work closely with R&D, Systems, UX, Clinical, and Verification teams to embed usability throughout design controls.
• Communicate usability findings and recommendations to stakeholders, influencing design decisions and risk mitigations.
• Participate in requirement reviews and ensure usability considerations are reflected in requirements and design.
  
  
  

• Analyze post‑market feedback and field insights to identify usability problems and propose design improvements.
• Provide usability training, coaching, and best‑practice guidance within project teams.
  
  
  

• Bachelor’s or Master’s degree in Human Factors Engineering, HCI, Cognitive Science, Industrial Design, Biomedical Engineering, or related field.
• 5+ years of experience in usability engineering, usability testing, UX, or human‑centered design, preferably in medical devices or healthcare technology.
• Strong knowledge of usability standards and regulatory guidance including IEC 62366‑1, FDA Human Factors Guidance, and HE75.
• Experience planning, executing, and documenting usability studies in regulated environments.
• Ability to conduct task analysis, workflow evaluations, and contextual research in clinical environments.
• Experience working with complex medical systems involving hardware, software, and integrated workflows.
• Excellent communication, cross‑functional collaboration, and documentation skills.
• Ability to work independently, drive usability activities, and influence stakeholders.
  
  
  

• Strong user advocacy and patient‑safety mindset.
• Analytical and systems‑thinking approach.
• Ability to challenge design decisions constructively and improve design quality.
• Adaptability and ability to work independently in complex development environments.