Senior System Test Engineer

TAE Life Sciences; Irvine, Northern (CA, KY); Hybrid; USD 140,000 - 165,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Paid vacation and sick time

Wellness program

Parental leave

Job summary

TAE Life Sciences (TLS) is seeking a System Test Engineer within the Quality organization to verify and validate complex medical device systems. You will develop, maintain, and execute test cases supporting Design Verification, Design Validation, and Usability Engineering, collaborating with Systems, Hardware, and Software teams as well as the Clinical group.

The role requires experience in regulated environments and familiarity with ISO standards; travel to customer installations is expected.

Qualifications

• BS in engineering, CS, or technical field.
• Minimum 5 years of system-level verification and validation experience.
• Experience with medical devices or regulated industries preferred.
• Strong analytical thinking and attention to detail.
• Excellent writing skills for test cases.

Responsibilities

• Develop and recommend verification and validation strategies for medical devices.
• Create and maintain plans for Design Verification, Design Validation, and Usability activities.
• Review architecture, requirements, and design documents.
• Derive and implement effective test cases to verify requirements and user needs.
• Execute tests and record results accurately.
• Document defects with detail to aid troubleshooting.
• Maintain traceability between requirements, tests, and risk controls.
• Adhere to SOPs and quality policies in the QMS.
• Coordinate with development teams to ensure Design Controls meet needs.
• Represent Quality in design reviews and testing discussions.

Skills

Analytical skills

Problem solving

Technical writing

Cross-functional collaboration

System test experience

Education

Bachelor’s degree in Engineering/CS

Job description

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.

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.

#LI- Onsite

About Us

Imagination, skill, and will

We are a diverse team of over 500 engineers, scientists, professionals, Maxwell Prize winners, and big thinkers from more than 40 countries with a track record of delivering on the innovative ways science can lead humanity into a brighter era. We are not afraid to envision a future where fusion and science can transform our world.

What you'll get with us

• Generous benefits such as Medical, Dental, Vision, 401 (K) with company match, paid vacation + sick time, companywide December holiday, wellness program, parental leave
• Payment rewards: For referring talent, novel research, and patents
• A collaborative environment: An organization where talents and interests can plug in to different groups throughout the organization
• Potential for equity participation
• HQ in Southern California
• Employee events on and off-site
• A commitment to upholding and growing an inclusive organization

TAE Technologies is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

We ensure all individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us [e-mail] to request accommodations or request more information.

Note to Agencies: TAE prefers to hire directly and maintains an existing preferred supplier list. We do not accept speculative CVs or referrals from agencies. If speculative CVs are sent, no fee will be applicable.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.