Senior System Test Engineer: Medical Device Verification

TAE Technologies, Inc

Irvine (CA)

On-site

USD 140,000 - 165,000

Full time

2 days ago
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Benefits offered by this job

Medical Benefits
Dental & Vision
Retirement Plan
Paid Time Off
Equity Potential

Job summary

TAE Life Sciences (TLS) in Irvine, CA is seeking a System Test Engineer to verify and validate complex medical device systems. You will develop verification strategies, write and execute test cases, and ensure design controls align with ISO 13485 and IEC standards with input from hardware, software, and clinical teams.

You will review architecture and requirements, document defects with reproducibility, and maintain traceability across requirements, tests, results, and risk controls while

Qualifications

  • Bachelor’s degree in Engineering, Computer Science, or related technical field.
  • At least 5 years of experience in system-level verification and validation of complex systems.
  • Experience with medical devices or regulated industries preferred.
  • Hands-on testing and troubleshooting of complex technical systems.

Responsibilities

  • Develop and maintain verification and validation strategies and test plans.
  • Create and execute test cases to verify requirements and validate user needs.
  • Review architecture, requirements, and design documents for testability.
  • Document defects with reproducible steps to aid troubleshooting.
  • Maintain traceability between requirements, tests, results, and risks.
  • Coordinate with cross-functional teams and adhere to SOPs and QMS.

Skills

Analytical thinking
Problem solving
Technical writing
Team collaboration
Experience with medical devices

Education

BS in Engineering/CS

Job description

TAE Life Sciences (TLS) in Irvine, CA is seeking a System Test Engineer to verify and validate complex medical device systems. You will develop verification strategies, write and execute test cases, and ensure design controls align with ISO 13485 and IEC standards with input from hardware, software, and clinical teams.

You will review architecture and requirements, document defects with reproducibility, and maintain traceability across requirements, tests, results, and risk controls while

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