Senior System Test Engineer – Medical Device QA, Onsite

Fusion Energy Base; Irvine (CA); On-site; USD 140,000 - 165,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision Coverage

401(k) with company match

Paid vacation & sick time

Equity opportunities

Job summary

TAE Life Sciences is seeking a System Test Engineer to join the Quality organization at our Irvine, CA location. You will develop, maintain, and execute test plans to support Design Verification, Design Validation, and Usability Engineering for our medical device systems.

The role requires strong analytical skills, experience with complex, computer-controlled systems, and the ability to collaborate with cross-functional teams including Systems, Hardware, and Software Engineering.

Qualifications

• Strong analytical and problem-solving skills with attention to detail.
• Ability to critically evaluate system requirements for completeness and testability.
• Excellent writing skills for technical test cases and reports.

Responsibilities

• Develop and implement verification and validation strategies for medical device products.
• Create and maintain plans for Design Verification, Design Validation, and Usability Engineering activities.
• Review architecture, requirements, and designs related to products under development.
• Derive and execute effective test cases to verify requirements and user needs.
• Record test results accurately and document defects with reproducibility details.
• Maintain bidirectional traceability between requirements, test cases, results, and risk controls.

Skills

Analytical skills

Problem solving

Technical writing

Cross-functional collaboration

System verification

Education

Bachelor’s degree in Engineering/Computer Science/Other Technical Discipline

Job description

TAE Life Sciences is seeking a System Test Engineer to join the Quality organization at our Irvine, CA location. You will develop, maintain, and execute test plans to support Design Verification, Design Validation, and Usability Engineering for our medical device systems.

The role requires strong analytical skills, experience with complex, computer-controlled systems, and the ability to collaborate with cross-functional teams including Systems, Hardware, and Software Engineering.