Pharmavise Corporation · 3 weeks ago
Firmware Test Engineer III — Verification & Validation (Onsite — Irvine, CA) Possible Temp-to-Hire
Irvine, CA
Contract
Onsite
Senior Level
5+ years expPharmavise Corporation is seeking a Firmware Test Engineer to join the Urology team for a 1-year assignment. This role will focus on verification and validation of embedded firmware used in Class III active implantable medical devices, developing automated and manual test solutions to ensure compliance with regulatory guidance.
Food and BeverageHealth Care
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
Qualification
Required
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
Preferred
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
Company
Pharmavise Corporation
♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2020-04-04Seed
Leadership Team
Ricardo Joseph
Founder and CEO
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