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.
• 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 obtain a passport and necessary visas required.
• 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.

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 (non-Sr., Sr., Lead or Manager). The compensation range for these roles are $110,000 - $130,000 annually.

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