Senior Medical Device System Test Engineer

Physics World; Lake Forest (CA); On-site; USD 140,000 - 165,000; Full time

Benefits offered by this job

Medical benefits

Dental insurance

Vision insurance

401(k) with company match

Paid vacation and sick time

Holidays

Wellness program

Parental leave

Equity participation

Job summary

TAE Life Sciences (TLS) is seeking a System Test Engineer to verify and validate complex medical device systems within the Quality organization. You will develop test strategies, maintain plans for Design Verification/Validation and Usability activities, and collaborate with Systems, Hardware, Software, and Clinical teams to ensure robust testing across the product lifecycle.

You will work with international standards (ISO 13485, IEC 62304) and support Quality with documentation, risk controls,

Qualifications

• Bachelor’s degree in Engineering/CS or related technical discipline.
• Minimum 5 years of experience in system-level verification and validation.
• Experience with medical devices or highly regulated industries preferred.
• Familiarity with Design Controls and quality standards is a plus.

Responsibilities

• Develop and implement verification and validation strategies, including test methods and environments.
• Create and maintain plans for Design Verification, Design Validation, and Usability activities.
• Review architecture, requirements and design documentation for testability and traceability.
• Derive effective test cases to verify requirements and user needs for products under development.
• Execute test cases and record results with clear reproducibility in defect tracking.
• Establish bidirectional traceability between requirements, tests, results and risk controls.
• Train and adhere to SOPs and QMS documentation related to Design Controls.
• Coordinate with development teams to ensure Design Controls meet needs and templates are used.
• Represent the Quality department in design reviews and testing discussions.

Skills

System verification

System validation

Test case development

Cross-functional collaboration

Analytical thinking

Technical writing

Education

Bachelor’s degree in Engineering/Computer Science/Technical Discipline

Job description

TAE Life Sciences (TLS) is seeking a System Test Engineer to verify and validate complex medical device systems within the Quality organization. You will develop test strategies, maintain plans for Design Verification/Validation and Usability activities, and collaborate with Systems, Hardware, Software, and Clinical teams to ensure robust testing across the product lifecycle.

You will work with international standards (ISO 13485, IEC 62304) and support Quality with documentation, risk controls,