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Firmware Test Engineer III — Verification & Validation; Onsite — Irvine, CA Temp
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2025-12-27
Listing for:
Pharmavise Corporation
Seasonal/Temporary, Contract
position Listed on 2025-12-27
Job specializations:
-
Software Development
Software Engineer, Software Testing
Job Description & How to Apply Below
Job Summary
We are seeking a Firmware Test Engineer to join the Urology team for a 1-year assignment. This role will focus on verification and validation (V&V) of embedded firmware used in Class III active implantable medical devices. The engineer will develop automated and manual test solutions, ensure compliance with IEC 62304 and other regulatory guidance, and contribute to the delivery of safe, reliable, and compliant firmware systems.
Key Responsibilities- Develop and execute test plans, protocols, and reports for firmware verification and validation in compliance with IEC 62304 and FDA regulations.
- Design, implement, and maintain test automation frameworks and tools to support continuous integration and testing.
- Collaborate with software developers and system engineers to identify test requirements and ensure comprehensive coverage.
- Support test infrastructure development, including hardware-in-the-loop setups and simulation environments.
- Prepare, develop, and execute risk-based product software testing (Unit & Integration Tests) in compliance with IEC 62304, 60601, and other applicable standards.
- Prepare high‑quality test deliverables aligned with ISO 14971 for regulatory submissions.
- Support both product and manufacturing process software test method development, verification and validation.
- Participate in design and code reviews, and associated integration activities.
- Bachelor’s degree in computer science, software engineering, electrical engineering, or related field.
- 5+ years of experience in software testing for regulated environments, preferably medical devices.
- Practical and working knowledge of C#, TES framework, IEC 62304, IEC 60601, and ISO 14971.
- Strong understanding of verification and validation processes for Class III medical devices.
- Experience with test automation, scripting, and CI/CD tools (Jenkins, Bitbucket, JIRA).
- Demonstrated ability to generate compliant documentation for audits and regulatory submissions.
- Experience with Class III active implantable firmware verification.
- Familiarity with risk‑based test approaches and traceability management tools (Cognition Cockpit).
- Familiarity with product integration projects and global team collaboration is a plus.
Schedule:
08:00 AM – 04:30 PM
Work Setup:
Onsite in Irvine, CA
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