Design Verification Test Engineer I
$110,240–$114,400 year
On-siteGoleta, California, United States
Job Summary
Develop design verification test protocols tracing directly to product requirements, defining test methods, sample sizes, and acceptance criteria. Execute verification testing on device hardware and systems, including functional, electrical, mechanical, environmental, and reliability testing, while operating equipment correctly and recording raw data with full traceability. Analyze test results against acceptance criteria, investigate failures to root cause, and author clear verification test reports suitable for regulatory submissions. Support test fixture development, design reviews, and risk management activities while maintaining traceability between requirements and results for audit compliance. Manage test sample logistics, build coordination, and laboratory scheduling to ensure testing runs to plan.
Required Qualifications
- A bachelor's degree in engineering, such as biomedical, mechanical, electrical, or a closely related discipline
- Equivalent demonstrated experience in a test engineering role
- Hands-on testing experience in a product development or manufacturing environment
- Experience including protocol execution
- Experience including data collection
- Experience including technical report writing
- Strong technical documentation skills
- Disciplined attention to detail
- Practical competency with test equipment
- Practical competency with measurement instrumentation
- Data analysis capability
- Ability to work onsite in Goleta, California for the full assignment
Desired Qualifications
- Prior medical device industry experience
- Working familiarity with design control requirements under 21 CFR Part 820
- Working familiarity with ISO 13485
- Exposure to IEC 60601 electrical safety testing
- Risk management under ISO 14971
- Statistical analysis
- Sample size justification
- Test automation or scripting in tools such as Python or LabVIEW
- Experience with electromechanical devices
- Experience with optics
- Experience with imaging systems
- Familiarity with design of experiments
- Familiarity with reliability and life testing
- Familiarity with package and sterilization validation
- Familiarity with change control processes for design modifications
- Exposure to verification activity supporting FDA submissions
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