Medical Device System Test Engineer

TAE Life Sciences U.S. LLC; 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

Wellness program

Parental leave

Equity participation

Job summary

TAE Technologies TLS is seeking a System Test Engineer to verify and validate complex medical device systems within the Quality organization. You will collaborate with Systems, Hardware, and Software teams, and contribute to usability engineering plans and risk control activities.

You will develop and execute test cases, document results, and help maintain bidirectional traceability from requirements to test outcomes while adhering to ISO 13485 and related standards. Onsite in Irvine, CA.

Qualifications

• Bachelor’s degree in Engineering/CS or related technical discipline.
• 2+ years of experience testing computer or mechanical systems preferred.
• Familiarity with Design Verification, Design Validation, and Usability Engineering.

Responsibilities

• Assist senior testers in developing verification and validation strategies.
• Develop and maintain plans for Design Verification, Design Validation, and Usability Engineering activities for products under development.
• 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.
• Assist senior members of the testing team in establishing and maintaining 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.

Skills

Verification & validation

Test automation

Medical device testing

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/CS or technical discipline

Job description

TAE Technologies TLS is seeking a System Test Engineer to verify and validate complex medical device systems within the Quality organization. You will collaborate with Systems, Hardware, and Software teams, and contribute to usability engineering plans and risk control activities.

You will develop and execute test cases, document results, and help maintain bidirectional traceability from requirements to test outcomes while adhering to ISO 13485 and related standards. Onsite in Irvine, CA.