Senior Medical Device System Test Engineer

TAE Life Sciences; Irvine, Northern (CA, KY); Hybrid; USD 140,000 - 165,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Paid vacation and sick time

Wellness program

Parental leave

Job summary

TAE Life Sciences (TLS) is seeking a System Test Engineer within the Quality organization to verify and validate complex medical device systems. You will develop, maintain, and execute test cases supporting Design Verification, Design Validation, and Usability Engineering, collaborating with Systems, Hardware, and Software teams as well as the Clinical group.

The role requires experience in regulated environments and familiarity with ISO standards; travel to customer installations is expected.

Qualifications

• BS in engineering, CS, or technical field.
• Minimum 5 years of system-level verification and validation experience.
• Experience with medical devices or regulated industries preferred.
• Strong analytical thinking and attention to detail.
• Excellent writing skills for test cases.

Responsibilities

• Develop and recommend verification and validation strategies for medical devices.
• Create and maintain plans for Design Verification, Design Validation, and Usability activities.
• Review architecture, requirements, and design documents.
• Derive and implement effective test cases to verify requirements and user needs.
• Execute tests and record results accurately.
• Document defects with detail to aid troubleshooting.
• Maintain traceability between requirements, tests, and risk controls.
• Adhere to SOPs and quality policies in the QMS.
• Coordinate with development teams to ensure Design Controls meet needs.
• Represent Quality in design reviews and testing discussions.

Skills

Analytical skills

Problem solving

Technical writing

Cross-functional collaboration

System test experience

Education

Bachelor’s degree in Engineering/CS

Job description

TAE Life Sciences (TLS) is seeking a System Test Engineer within the Quality organization to verify and validate complex medical device systems. You will develop, maintain, and execute test cases supporting Design Verification, Design Validation, and Usability Engineering, collaborating with Systems, Hardware, and Software teams as well as the Clinical group.

The role requires experience in regulated environments and familiarity with ISO standards; travel to customer installations is expected.