System Test Engineer
Listed on 2026-08-23
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Engineering
Quality Engineering, Biomedical Engineer, Test Engineer, Medical Device Industry
Copernicus Office TLS
9750 Irvine Blvd
Irvine, CA 92618, USA
Copernicus Office TLS
9750 Irvine Blvd
Irvine, CA 92618, USA
TAE Life Sciences (TLS) is a biologically targeted radiation therapy company focused
on developing novel treatment to improve the lives of patients with difficult-to-treat cancers. TLS has
developed breakthrough technology for the clinical investigation of Boron Neutron Capture Therapy
(BNCT) to provide a treatment option for patients with malignancies that are difficult to treat through
traditional methods, such as head, neck and brain cancers. Our proprietary accelerator-based BNCT
platform combines two well-known modalities - biological targeting and radiation therapy - for precision
treatment at the cellular level.
Job Description
Embedded within the Quality organization, System Test Engineering roles provide independent technical
verification and validation of complex medical device systems while working closely with Systems,
Hardware, and Software Engineering teams as well as the Clinical team. The System Test Engineer is
responsible for the development, maintenance, and execution of test cases to support Design
Verification, Design Validation, and Usability Engineering activities for products designed and developed
by the company. A System Test Engineer reads and interprets requirements documents and other design
documentation and interacts with design engineers to ensure test cases properly verify the design
requirements and support validation of applicable user needs and intended uses. A System Test Engineer
also reads, understands, and executes plans for Design Verification, Design Validation, and Usability
Engineering and contributes to associated reports summarizing the testing efforts.
A System Test Engineer will become familiar with applicable international standards associated with
medical device development and quality management (ISO 13485, ISO 14971, IEC 62304, and IEC 62366)
and can also support the Quality department with other work when workload permits.
About the Role
- Assist senior members of the testing team in developing verification and validation strategies,
including test methods, test levels, sequencing, required environments, and appropriate use of
analysis, inspection, demonstration, and testing. - Assist senior members of the testing team in developing and maintaining plans for Design
Verification, Design Validation, and Usability Engineering activities for products under
development. - Derive effective and efficient test cases to verify requirements and validate applicable user needs
and intended uses for the products under development. - Execute test cases on assigned systems and accurately record the results.
- Identify, document, and characterize defects discovered during test execution with sufficient
technical detail and reproducibility information to assist in troubleshooting and allow further
evaluation by the development team. - Assist senior members of the testing team in establishing and maintaining bidirectional
traceability between requirements, test cases, test results, and risk control measures. - Train to and adhere to all relevant SOPs, work instructions, and company policies as part of TAE
Life Science’s Quality Management System.
About You
- Demonstrated aptitude and desire to learn verification, validation, usability engineering, and
medical device design controls in a regulated medical device environment. - Strong analytical and problem-solving skills, demonstrating sound judgment and understanding of
technical context with exceptional attention to detail. - Strong technical writing skills, with the ability to clearly document test methods, observations,
results, and technical issues. - Ability to collaborate effectively with cross-functional teams.
- Ability to carefully follow documented test procedures while recognizing, documenting, and
communicating unexpected system behavior or discrepancies. - Strong technical/mechanical aptitude with demonstrated problem-solving and troubleshooting
ability.
Education and Experience
- Bachelor’s degree (BS) in Engineering/Computer Science/Other Technical Discipline.
- Two or more years of experience testing computer or mechanical systems preferred but not
required…
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