Senior 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

Strong analytical and problem-solving skills, demonstrating sound judgment and understanding of technical context with exceptional attention to detail.
Demonstrated ability to critically evaluate system and subsystem requirements for completeness, clarity, consistency, testability, and objective acceptance criteria.
Excellent technical/mechanical reasoning and problem solving.
Excellent writing skills in creating technical test cases.
Demonstrated ability to collaborate effectively with cross-functional teams.
Experience in complex computer-controlled systems incorporating hardware, software, and electromechanical subsystems.
Bachelor’s degree (BS) in Engineering/Computer Science/Other Technical Discipline.
Minimum 5 years of progressively responsible experience performing system-level verification and validation of complex systems, preferably medical devices or products developed in another highly regulated industry.
Demonstrated curiosity, initiative, and interest in hands-on testing and troubleshooting of complex technical systems.
Ability to travel to domestic and international customer installations.
Ability to work on site at our Orange County (Irvine) location.
Ability and desire to perform testing activities at customer installations including extended duration assignments up to 90 calendar days per year.
Capable of working in safe proximity to residual radiation (with proper PPE).
Capable of climbing steps (less than 30) around a medical device.

Nice To Haves

Radiation oncology device experience is preferred but not required.
Current passport desired.

Responsibilities

Develop and recommend verification and validation strategies, including test methods, test levels, sequencing, required environments, and appropriate use of analysis, inspection, demonstration, and testing.
Develop and maintain plans for Design Verification, Design Validation, and Usability Engineering activities for products under development.
Review and critique all architecture, requirements, and design documents associated with products under development.
Independently 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.
Establish and maintain 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.
Create and maintain Quality Management System documents concerning Design Controls.
Coordinate with development teams to ensure current Design Controls procedures, work instructions, and templates are sufficient to meet their needs.
Represent the Quality department in meetings, design reviews, and/or discussions involving testing or design controls.