Senior Human Factors Engineer – MedTech Usability & MDR/FDA

CMR Surgical Ltd.; Town of Cambridge; On-site; AUD 115,000 - 173,000; Full time

Job summary

CMR Surgical Ltd. is seeking a Senior Usability Engineer to plan and execute usability activities for new system designs and UFMEA workstreams.

You will lead formative and summative studies, assess usability impacts on protocols, and collaborate with design teams to determine the depth of activity required. The role requires experience with MDR/FDA regulated devices, risk management documentation, and travel to the USA to support studies.

Qualifications

• Experience in planning and executing usability activities for complex product designs.
• Strong ability to communicate clearly and document findings.

Responsibilities

• Plan, moderate and report formative and summative usability studies.
• Compile documentation to meet regulatory requirements.
• Create and maintain UFMEA and risk documents (critical task lists).
• Support Human Factors objectives across projects.

Job description

CMR Surgical Ltd. is seeking a Senior Usability Engineer to plan and execute usability activities for new system designs and UFMEA workstreams.

You will lead formative and summative studies, assess usability impacts on protocols, and collaborate with design teams to determine the depth of activity required. The role requires experience with MDR/FDA regulated devices, risk management documentation, and travel to the USA to support studies.