Senior Firmware Engineer

Firmware Test Engineer (1‑Year Contract and then option to go perm)

Industry: Class III Active Implantable Medical Devices

Pay Rate: $82/hr

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. The 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 cross‑functional teams to support both product development and manufacturing software testing needs.

• Develop and execute test plans, protocols, and reports in accordance with IEC 62304 and FDA regulatory requirements.
• Prepare and perform risk‑based software testing (unit and integration) aligned with IEC 62304, IEC 60601, and other applicable standards.
• Produce high‑quality test deliverables that meet ISO 14971 expectations for regulatory submissions.

• Design, implement, and maintain test automation frameworks and tools to support continuous integration and continuous testing.
• Support development of test infrastructure, including hardware‑in‑the‑loop (HIL) systems and simulation environments.

• 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.

• 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).
• Hands‑on experience with:
• C#
• 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.

• Familiarity with risk‑based testing and traceability tools (e.g., Cognition Cockpit).
• Experience supporting product integration projects and collaborating with global teams.

Mid‑Senior level

Contract

Medical Equipment Manufacturing

• 401(k)
• Vision insurance
• Medical insurance