Job Description

Job Title: Test Engineer – FDA Usability / Human Factors

About the Role

We are looking for a Test Engineer specializing in Usability and Human Factors to support our medical device products in the US market.

You will be responsible for testing whether doctors and other medical professionals can use our products safely, correctly, and easily. You will work closely with R&D, Regulatory Affairs, and Quality teams to identify potential user errors and improve product design.

Key Responsibilities

• Design and conduct usability and human factors tests for medical devices.
• Develop test plans, test scenarios, and evaluation criteria.
• Recruit and work with target users, such as doctors and healthcare professionals , for usability testing.
• Observe and analyze how users interact with the product and identify potential use errors and safety risks .
• Work with R&D teams to identify and resolve usability-related problems.
• Conduct both formative and summative usability testing during product development.
• Analyze test results and prepare usability test reports and documentation .
• Support the preparation of usability and human factors documentation required for FDA submissions .
• Work closely with Regulatory Affairs and Quality teams to ensure testing and documentation meet US FDA requirements .

Requirements

• Bachelor's or Master's degree in Engineering, Human Factors, Usability Engineering, Biomedical Engineering , or a related field.
• Experience in medical device testing, usability engineering, or human factors engineering .
• Understanding of FDA usability / human factors requirements .
• Experience designing or conducting usability tests is highly preferred.
• Strong analytical and problem-solving skills.
• Good English communication and documentation skills.
• Experience working with R&D and cross-functional teams.

Nice to Have

• Experience with FDA medical device submissions .
• Knowledge of IEC 62366 or other medical device usability standards.
• Experience with surgical or robotic medical devices .
• Experience working directly with doctors or healthcare professionals during usability testing.

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