Senior System Test Engineer
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.
Requirements
- 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.
Qualifications
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.
Skills
- 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.
Benefits
- Medical, Dental, Vision coverage.
- 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.
- Collaborative environment where talents and interests can plug in to different groups.
- Potential for equity participation.
- Headquarters in Southern California.
- Employee events on and off-site.
- Commitment to upholding and growing an inclusive organization.
Pay
The compensation range for this position