Firmware Test Engineer

Firmware Test Engineer

This hands-on Firmware Test Engineer role focuses on owning verification and validation activities for a Class III medical device program. You will develop, execute, and maintain firmware verification testing, ensure requirements traceability, support regulatory submissions, and drive testing efforts during the final stages of product development. This position offers the opportunity to make a direct impact on a life-sustaining medical device, work in a high-visibility role during a critical product milestone, and help build a scalable verification organization while collaborating closely with Firmware, Systems, Quality, and Regulatory teams.

Responsibilities:

• Execute firmware verification and validation activities for a regulated Class III medical device.
• Review, update, refine, and execute existing verification plans and test protocols to ensure thorough coverage and compliance.
• Author and maintain verification plans, test protocols, test reports, and Design History File (DHF) documentation.
• Establish and maintain requirements-to-test-to-results traceability, including building and updating requirements traceability matrices.
• Perform manual firmware and system-level testing of embedded and firmware-controlled devices in a lab environment.
• Conduct requirements-based testing and risk-based testing aligned with medical device development standards.
• Participate in risk assessments, risk reviews, and mitigation activities to support product safety and reliability.
• Support FDA submission readiness and compliance activities by preparing and organizing verification and validation documentation.
• Investigate test failures and collaborate directly with firmware and engineering teams to perform root cause analysis and drive resolution.
• Support commercialization activities and future remediation efforts by contributing to verification strategies and documentation updates.
• Contribute to the development of scalable verification processes and help shape future team expansion and organizational growth.
• Update and improve existing test protocols to reflect evolving requirements, design changes, and process improvements.
• Review system and firmware requirements and create traceability links between requirements, tests, and test results.
• Work closely with firmware engineers and cross-functional partners in Systems, Quality, and Regulatory to address issues and optimize testing approaches.
• Participate in regulatory discussions and submission readiness activities, ensuring documentation is complete, accurate, and audit-ready.

Essential Skills:

• Hands-on experience performing firmware and embedded systems testing, with a strong understanding of verification and validation methodologies.
• Proven experience with requirements-based testing, including translating requirements into test cases and protocols.
• Demonstrated experience with risk-based testing in a regulated environment, particularly for safety-critical products.
• Ability to build and maintain requirements traceability matrices that link requirements, test cases, and test results.
• Hands-on testing experience with embedded devices and firmware-controlled products, including manual system-level testing.
• Knowledge of I2C communication protocol and its application in embedded systems.
• Knowledge of SPI communication protocol and its application in embedded systems.
• Experience with hardware/software integration testing for embedded and electromechanical systems.
• Experience working within a regulated industry environment, such as medical devices, with familiarity in compliance expectations.
• Experience creating and maintaining DHF documentation, including verification plans, test protocols, and test reports.
• Strong documentation and technical writing skills, with the ability to produce clear, accurate, and audit-ready test documentation.
• Experience with firmware verification and validation testing for embedded systems.
• Understanding of medical device verification documentation requirements and standards.
• Experience with embedded systems testing software and tools used in firmware test environments.
• Familiarity with risk-based testing practices and requirements-based testing and traceability in regulated industries.

Additional Skills & Qualifications:

• Experience working on Class II or Class III medical devices, particularly in verification and validation roles.
• Experience supporting FDA submissions, including preparation of verification and validation documentation for regulatory review.
• Pump-based medical device experience, especially with life-sustaining or infusion technologies.
• Electromechanical device experience, including testing systems that combine mechanical components with embedded firmware.
• Exposure to test automation frameworks and tools, with the ability to contribute to automation strategies for verification.
• Experience scaling verification processes or teams, including developing standardized methods, templates, and best practices.
• Familiarity with regulated industry standards such as IEC and ISO relevant to medical device development and testing.
• Regulated industry experience beyond medical devices, with an understanding of compliance, documentation, and audit requirements.
• Strong cross-functional collaboration skills, with the ability to work effectively with Firmware, Systems, Quality, and Regulatory groups.
• Interest in influencing process improvements and testing strategy as part of building a robust verification organization.

Work Environment:

This role is primarily onsite in Maple Grove, MN, with an expectation of working in the office 3–4 days per week. You will operate in a lab-based environment focused on testing embedded and firmware-controlled medical devices, using embedded systems testing software, tools, and equipment suitable for hardware/software integration and protocol-level testing (including I2C and SPI). The position offers direct involvement in a critical product milestone for a Class III life-sustaining medical device, high visibility across cross-functional teams, and the opportunity to shape verification processes as the organization grows. The environment emphasizes collaboration with Firmware, Systems, Quality, and Regulatory teams, adherence to regulated industry standards such as IEC and ISO, and readiness for FDA submissions.