New

Senior Firmware Engineer (Med Device)

Advantage Technical
$82.00-$82.00
paid time off, paid holidays
United States, California, Irvine
Dec 17, 2025
Firmware Test Engineer (1Year Contract and then option to go perm) Industry: Class III Active Implantable Medical Devices Pay Rate: $82/hr Position Overview We are seeking a Firmware Test Engineer to support verification and validation (V&V) activities for embedded firmware used in Class III active implantable medical devices. This role involves developing automated and manual test solutions, ensuring compliance with IEC 62304 and other regulatory standards, and contributing to the delivery of safe, reliable, and compliant firmware systems. The engineer will work closely with crossfunctional teams to support both product development and manufacturing software testing needs. Key Responsibilities Firmware Verification & Validation Develop and execute test plans, protocols, and reports in accordance with IEC 62304 and FDA regulatory requirements. Prepare and perform riskbased software testing (unit and integration) aligned with IEC 62304, IEC 60601, and other applicable standards. Produce highquality test deliverables that meet ISO 14971 expectations for regulatory submissions. Automation & Test Infrastructure Design, implement, and maintain test automation frameworks and tools to support continuous integration and continuous testing. Support development of test infrastructure, including hardwareintheloop (HIL) systems and simulation environments. CrossFunctional Collaboration Work with software developers and system engineers to define test requirements and ensure comprehensive test coverage. Participate in design reviews, code reviews, and integration activities. Support test method development for both product firmware and manufacturing process software. Required Qualifications Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or a related field. 5+ years of software testing experience in regulated environments (medical device experience strongly preferred). Handson experience with: C# Test automation frameworks CI/CD tools (e.g., Jenkins, Bitbucket, JIRA) Working knowledge of IEC 62304, IEC 60601, ISO 14971, and V&V processes for Class III medical devices. Proven ability to produce compliant documentation for audits and regulatory submissions. Preferred Qualifications Experience testing firmware for Class III active implantable devices. Familiarity with riskbased testing and traceability tools (e.g., Cognition Cockpit). Experience supporting product integration projects and collaborating with global teams. The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on various factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee. The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off. After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Us Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies. Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.