What are the responsibilities and job description for the Test Validation Engineer position at Eliassen Group?
Description
Onsite in San Diego, CA
Our client seeks a Test Validation Engineer to lead software verification and validation for regulated medical device manufacturing systems. The role focuses on translating user needs into testable requirements, authoring protocols, executing system-level testing, and producing compliant V&V documentation. Experience with 21 CFR Part 820, measurement systems analysis using JMP, and LabVIEW in NI-based test environments will support success. The engagement is remote-first with limited onsite time for system learning and collaboration.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $52.00 to $62.00/hr. w2
Responsibilities
Onsite in San Diego, CA
Our client seeks a Test Validation Engineer to lead software verification and validation for regulated medical device manufacturing systems. The role focuses on translating user needs into testable requirements, authoring protocols, executing system-level testing, and producing compliant V&V documentation. Experience with 21 CFR Part 820, measurement systems analysis using JMP, and LabVIEW in NI-based test environments will support success. The engagement is remote-first with limited onsite time for system learning and collaboration.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $52.00 to $62.00/hr. w2
Responsibilities
- Generate user requirements for systems containing software, hardware, firmware, and peopleware.
- Develop test plans and protocols to verify user and software requirements.
- Execute system-level testing and document objective evidence.
- Author software V&V reports including anomaly and deviation rationale.
- Drive release activities through the product lifecycle management system.
- Support release of ancillary documentation such as engineering studies and lab-book reports.
- Participate in cross-functional meetings and technical reviews.
- Partner with software developers and system designers across the SDLC.
- Apply basic statistics for measurement systems analysis, sampling, SPC, DOE using JMP.
- Perform limited white-box testing and debugging when applicable.
- 5 years of software verification and validation experience.
- Medical device domain experience with 21 CFR Part 820 compliance.
- Measurement Systems Analysis proficiency, including gage R&R, sampling strategies, SPC, DOE using JMP.
- Knowledge of LabVIEW and NI-based test environments.
- Ability to elicit and synthesize user, functional, and software requirements into testable specifications.
- High attention to detail with strong written communication for defect reporting and documentation.
- Knowledge of SDLC and GAMP 5 (preferred).
- Background in analytical or wet chemistry (preferred).
- Bachelor’s degree in Engineering or Computer Science.
Salary : $52 - $62