System Test Engineer

About the role

The System Test Engineer will join the Quality organization at TAE Life Sciences (TLS) to provide independent verification and validation of our accelerator‑based Boron Neutron Capture Therapy (BNCT) platform. Working on‑site in Irvine, the engineer will collaborate closely with systems, hardware, software and clinical teams to ensure that our medical‑device systems meet all design and regulatory requirements.

Key responsibilities

• Develop, maintain and execute detailed test cases for design verification, design validation and usability engineering activities.
• Interpret requirements documents, design specifications and user needs to create appropriate test procedures.
• Perform hands‑on testing of hardware, software and integrated system components, recording results and anomalies.
• Generate test reports, summarize findings and work with design engineers to resolve issues.
• Support compliance with international medical‑device standards (e.g., ISO 13485, IEC 60601).

Required profile

• Bachelor’s degree in Electrical, Mechanical, Biomedical or related engineering discipline.
• Experience in system‑level testing of complex medical devices or similar regulated products.
• Strong analytical skills and ability to read and interpret technical documentation.
• Excellent communication skills to interact with cross‑functional teams.

Required skills

• System test planning and execution.
• Design verification and validation methodologies.
• Usability engineering testing.
• Familiarity with medical‑device regulatory standards.