System Test Engineer: Medical Device Verification & Validation

Fusion Energy Base; Irvine (CA); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(K) with company match

Paid vacation + sick time

Company-wide December holiday

Wellness program

Parental leave

Referral rewards

Job summary

TAE Life Sciences is seeking a System Test Engineer to join the Quality organization in Southern California. The role focuses on developing and executing verification, validation, and usability tests for medical device products, aligning with ISO 13485, ISO 14971, IEC 62304, and IEC 62366 requirements.

You will collaborate with Systems, Hardware, and Software Engineering teams and contribute to test plans, defect analysis, and traceability across requirements and risk controls.

Qualifications

• Bachelor’s degree in Engineering/CS/Technical Discipline required.
• Two or more years of experience testing computer or mechanical systems preferred.
• Aptitude and desire to learn verification, validation, usability engineering, and medical device design controls in a regulated environment.

Responsibilities

• Assist senior testing members in developing verification and validation strategies, including test methods and environments.
• Develop and maintain plans for Design Verification, Design Validation, and Usability Engineering activities.
• Derive effective test cases to verify requirements and validate user needs for products under development.
• Execute test cases on assigned systems and record results.
• Document defects with detail to aid troubleshooting and evaluation by the development team.
• Maintain bidirectional traceability between requirements, test cases, results, and risk controls.
• Follow SOPs, work instructions, and company policies as part of Quality Management System.

Skills

Verification

Validation

Usability engineering

Test planning

Technical writing

Cross-functional collaboration

Troubleshooting

Education

Bachelor’s degree in Engineering/CS/Technical Discipline

Job description

TAE Life Sciences is seeking a System Test Engineer to join the Quality organization in Southern California. The role focuses on developing and executing verification, validation, and usability tests for medical device products, aligning with ISO 13485, ISO 14971, IEC 62304, and IEC 62366 requirements.

You will collaborate with Systems, Hardware, and Software Engineering teams and contribute to test plans, defect analysis, and traceability across requirements and risk controls.