System Test Engineer

TAE Technologies•Irvine, CA

1d•Onsite

About The Position

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. 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.

Requirements

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.
Bachelor’s degree (BS) in Engineering/Computer Science/Other Technical Discipline.
Demonstrated curiosity, initiative, and interest in hands-on testing and troubleshooting of complex technical systems.

Nice To Haves

Two or more years of experience testing computer or mechanical systems preferred but not required.
Current passport desired.
Ability to obtain a passport and necessary visas required.

Responsibilities

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.