Usability Specialist (MedTech)

Job summary

This role focuses on ensuring that medical products meet user needs, safety standards, and regulatory requirements by applying usability and human factors engineering principles throughout the product lifecycle.

Qualifications

• Master’s degree in biomedical engineering, human factors engineering, ergonomics, usability engineering, interaction design, design & innovation, engineering psychology, or a related field.
• Experience with AI technologies to enhance efficiency and quality.
• Hands-on experience in usability testing and research, including defining research objectives, documentation, conducting studies, analyzing results, and reporting findings.
• Background in early-stage product development or concepting.

Responsibilities

• Plan and execute the usability engineering process in new product development.
• Apply standards such as ISO/IEC 62366, FDA Human Factors Guidance, ANSI/AAMI HE75, and ISO 14971.
• Conduct formative and summative usability studies.
• Facilitate analyses, workshops, reports, and presentations.
• Contribute to task analyses and cognitive walk-throughs.
• Provide recommendations based on user insights and usability standards.
• Support documentation and compliance with regulatory standards.
• Participate in initiatives to improve usability engineering practices.

Skills

• Strong analytical skills and ability to connect with users.
• Excellent stakeholder management and communication skills.
• Collaborative mindset and problem-solving abilities.

Education

• Master’s degree in a relevant field.

Tools

• Familiarity with usability testing tools and methodologies.