Medical Device System Test Engineer

TAE Technologies, Inc.; Irvine, Northern (CA, KY); Hybrid; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(K) with company match

Paid vacation & sick time

Companywide December holiday

Wellness program

Parental leave

Job summary

TAE Life Sciences is seeking a System Test Engineer to verify and validate complex medical device systems. You will work with Systems, Hardware, and Software teams, and the Clinical unit to develop tests that support Design Verification, Design Validation, and Usability activities.

The role requires learning relevant international standards (ISO 13485, 14971, IEC 62304/62366) and traveling to installations as needed. A BS in engineering or CS and 2+ years of testing experience are preferred.

Qualifications

• Bachelor’s degree in engineering, computer science, or a technical discipline.
• Two or more years of experience testing computer or mechanical systems preferred but not required.
• Curiosity and hands-on testing mindset for complex technical systems.

Responsibilities

• Assist senior testers in developing verification and validation strategies, test methods, environments, and sequencing.
• Develop and maintain plans for Design Verification, Design Validation, and Usability Engineering activities.
• Derive effective test cases to verify requirements and user needs for products under development.
• Execute test cases on assigned systems and record results accurately.
• Document defects with details to aid troubleshooting and investigation by the development team.
• Establish bidirectional traceability between requirements, test cases, results, and risk controls.
• Train to and adhere to SOPs and company quality policies.

Skills

Test strategy development

Verification & Validation

Test case design

Defect documentation

Traceability

SOP adherence

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in Engineering/CS or related

Job description

TAE Life Sciences is seeking a System Test Engineer to verify and validate complex medical device systems. You will work with Systems, Hardware, and Software teams, and the Clinical unit to develop tests that support Design Verification, Design Validation, and Usability activities.

The role requires learning relevant international standards (ISO 13485, 14971, IEC 62304/62366) and traveling to installations as needed. A BS in engineering or CS and 2+ years of testing experience are preferred.