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

• 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.

About You

• 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.

Education and Experience

• 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.
• Radiation oncology device experience is preferred but not required.
• Demonstrated curiosity, initiative, and interest in hands-on testing and troubleshooting of
  complex technical systems.

Other Requirements (Travel, shift work, etc.)

• Ability to travel to domestic and international customer installations. Current passport desired.
• 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.

At TAE Technologies, we consider a wide range of factors when making compensation decisions including but not limited to skill sets; experience and job-related knowledge, training; licenses and certifications, and other business and organizational needs. The total compensation package for this position may also include other elements depending on the position offered (Sr., Lead or Manager). The compensation range for these roles are $140,000 - $165,000 annually.

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