Medical Device System Test Engineer – V&V Focus

TAE Technologies, Inc; 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

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 Engineering teams and the Clinical group to develop and execute test plans, ensuring designs meet user needs and intended uses.

Hone your skills in Design Verification, Design Validation, and Usability Engineering while adhering to ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

Qualifications

• Bachelor’s degree in Engineering/CS/Technical Discipline.
• 2+ years of experience testing computer or mechanical systems.
• Curiosity, initiative, and interest in hands-on testing and troubleshooting.

Responsibilities

• Assist senior members of the testing team in developing verification and validation strategies, including test methods, test levels, sequencing, required environments, and appropriate use of analysis, inspection, demonstration, and testing.
• Assist senior members of the testing team in developing and maintaining 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 and allow further evaluation by the development team.
• 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

Test planning

Verification

Documentation

Cross-functional collaboration

Analytical thinking

Education

Bachelor’s degree in Engineering/CS/Technical Discipline

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 Engineering teams and the Clinical group to develop and execute test plans, ensuring designs meet user needs and intended uses.

Hone your skills in Design Verification, Design Validation, and Usability Engineering while adhering to ISO 13485, ISO 14971, IEC 62304, and IEC 62366.