Firmware Engineer

Job Title: Firmware Test Engineer

Location: Maple Grove, MN

Work Environment: Onsite – 3–4 days per week

Local Candidates Only

Job Summary

We are seeking a hands-on Firmware Test Engineer to own verification and validation activities for a Class III medical device program.

This role will be responsible for developing, executing, and maintaining firmware verification testing, ensuring requirements traceability, supporting regulatory submissions, and driving testing efforts during the final stages of product development.

The successful candidate will work closely with Firmware, Systems, Quality, and Regulatory teams to support a critical product milestone for a life-sustaining medical device. This position also offers the opportunity to contribute to scalable verification processes and help shape the future growth of the verification organization.

Key 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 with firmware and engineering teams to perform root cause analysis and drive resolution.
• Support commercialization activities and future remediation efforts through verification strategies and documentation updates.
• Contribute to the development of scalable verification processes, standardized methods, templates, and best practices.
• 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, Systems, Quality, and Regulatory teams to address issues and optimize testing approaches.
• Participate in regulatory discussions and submission readiness activities, ensuring documentation is complete, accurate, and audit-ready.

Required Skills and Qualifications

• Hands-on experience performing firmware and embedded systems testing.
• Strong understanding of verification and validation methodologies.
• Experience with requirements-based testing and 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 linking requirements, test cases, and test results.
• Hands-on experience testing embedded devices and firmware-controlled products.
• Experience performing manual system-level testing in a lab environment.
• 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 in a regulated industry environment with familiarity with 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 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 requirements-based testing, risk-based testing, and traceability practices in regulated industries.

Preferred 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.
• Experience with pump-based medical devices, particularly life-sustaining or infusion technologies.
• Experience testing electromechanical devices that combine mechanical components with embedded firmware.
• Exposure to test automation frameworks and tools and the ability to contribute to automation strategies.
• Experience scaling verification processes or teams, including development of standardized methods, templates, and best practices.
• Familiarity with regulated industry standards such as IEC and ISO relevant to medical device development and testing.
• Experience working in regulated industries beyond medical devices, with an understanding of compliance, documentation, and audit requirements.
• Strong cross-functional collaboration skills with Firmware, Systems, Quality, and Regulatory teams.
• Interest in influencing process improvements and testing strategy while helping build a robust verification organization.

Work Environment

This position is primarily onsite in Maple Grove, MN, with an expectation of working in the office 3–4 days per week.

The engineer will work 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 role provides direct involvement in a critical product milestone for a Class III life-sustaining medical device and requires close collaboration across Firmware, Systems, Quality, and Regulatory teams.

Local candidates only.