System Test Engineer

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 biological targeting and radiation therapy for precision treatment at the cellular level.

About the Role

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:

• 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.
• Interpreting requirements documents and other design documentation, interacting with design engineers to ensure test cases properly verify design requirements and support validation of applicable user needs and intended uses.
• Reading, understanding, and executing plans for Design Verification, Design Validation, and Usability Engineering, contributing to associated reports summarizing testing efforts.
• Becoming familiar with applicable international standards associated with medical device development and quality management (ISO 13485, ISO 14971, IEC 62304, and IEC 62366).
• Supporting the Quality department with other work when workload permits.

Key responsibilities include:

• Assisting 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.
• Assisting in developing and maintaining plans for Design Verification, Design Validation, and Usability Engineering activities for products under development.
• Deriving effective and efficient test cases to verify requirements and validate applicable user needs and intended uses for products under development.
• Executing test cases on assigned systems and accurately recording results.
• Identifying, documenting, and characterizing defects discovered during test execution with sufficient technical detail and reproducibility information.
• Assisting in establishing and maintaining bidirectional traceability between requirements, test cases, test results, and risk control measures.
• Training to and adhering to all relevant SOPs, work instructions, and company policies as part of TAE Life Science’s Quality Management System.

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, with sound judgment and understanding of technical context, plus 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.

Qualifications

• Bachelor’s degree (BS) in Engineering, Computer Science, or other technical discipline.
• Two or more years of experience testing computer or mechanical systems (preferred but not required).
• Demonstrated curiosity, initiative, and interest in hands-on testing and troubleshooting of complex technical systems.

Other Requirements

• Ability to travel to domestic and international customer installations; current passport desired.
• Ability to obtain a passport and necessary visas.
• Ability and desire to perform testing activities at customer installations, including extended duration assignments up to 30-60 calendar days per year as necessary.
• Capable of working in safe proximity to residual radiation (with proper PPE).
• Capable of climbing steps (less than 30) around a medical device.

Pay

The compensation range for this role is $110,000 - $130,000 annually.

Benefits

• Generous benefits including Medical, Dental, Vision, and 401(k) with company match.
• Paid vacation + sick time, companywide December holiday, and wellness program.
• Parental leave.
• Payment rewards for referring talent, novel research, and patents.
• A collaborative environment with opportunities to engage with different groups throughout the organization.
• Potential for equity participation.
• Employee events on and off-site.
• Commitment to upholding and growing an inclusive organization.