V&V Test Engineer

Must Have Technical/Functional Skills

• 5+ years of hands-on testing experience in medical device or regulated industry

• Strong experience in: Executing IQ/OQ/PQ protocols, Protocol reading and step-by-step execution, Test data recording and documentation

• Familiarity with: Lab instruments (multimeters, oscilloscopes, sensors, etc.), Equipment validation processes

• Understanding of GxP and validation practices

• Experience with Veritas Console or similar medical equipment

• Exposure to equipment validation in manufacturing or R&D labs

Roles & Responsibilities

We are looking for a hands-on V&V Test Engineer responsible for executing validation protocols on medical device equipment (Veritas Console). The role primarily involves protocol-based testing, data recording, and documentation to ensure equipment meets defined performance and regulatory requirements.

Key Responsibilities

Protocol Execution

• Execute pre-approved validation protocols (IQ/OQ/PQ) for medical equipment such as Veritas Console.

• Follow detailed step-by-step test procedures and ensure strict adherence to instructions.

• Set up test environments, instruments, and equipment as per protocol requirements.

Testing Activities

• Perform functional, operational, and performance testing of equipment.

• Conduct tests under various conditions and scenarios defined in protocols.

• Capture accurate test results, observations, and evidence during execution.

Documentation & Reporting

• Record test results in protocol documents, logbooks, and validation reports.

• Document any deviations, anomalies, or failures observed during testing.

• Ensure completeness and compliance of executed protocols per quality standards.

Defect & Issue Handling

• Identify and report defects or non-conformances.

• Work closely with engineering and quality teams for issue resolution.

• Retest equipment after fixes as required.

Compliance & Quality

• Ensure all activities comply with:

o GxP guidelines

o FDA 21 CFR Part 820 / 11

o ISO 13485

• Maintain proper traceability and document control.

Equipment Handling

• Operate and handle medical equipment, test setups, and measurement instruments safely.

• Ensure calibration status of instruments before testing.

Salary Range: $80,000- $90,000 a year

TCS Employee Benefits Summary:

Discretionary Annual Incentive.

Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.

Family Support: Maternal & Parental Leaves.

Insurance Options: Auto & Home Insurance, Identity Theft Protection.

Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.

Time Off: Vacation, Time Off, Sick Leave & Holidays.

Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

#LI-SP1

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Role: Engineer

Desired skills: Medical Device NPD

Qualifications: BACHELOR OF COMPUTER SCIENCE

• Experience: 4 - 8 Years

• Job function: TECHNOLOGY

• Location: Irvine, CA

Salary range: $80,000–$90,000

Apply by: 2026-08-21 00:00:00