Firmware Test Engineer

We are seeking a hands-on Firmware Test Engineer to lead verification and validation activities for a Class III medical device program. You 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 ideal candidate will contribute as an individual contributor while growing their skills and responsibilities. Responsibilities

• Execute firmware verification and validation activities for a regulated medical device.
• Review, update, refine, and execute existing verification plans and test protocols.
• Author and maintain Verification Plans, Test Protocols, Test Reports, and Design History File (DHF) documentation.
• Establish and maintain requirements-to-test-to-results traceability.
• Perform manual firmware and system-level testing.
• Conduct risk-based testing aligned with medical device development standards.
• Participate in risk assessments and mitigation activities.
• Support FDA submission readiness and compliance activities.
• Investigate test failures and collaborate with engineering teams on root cause analysis.
• Support commercialization activities and future remediation efforts.
• Contribute to the development of scalable verification processes and future team expansion.

• Experience performing firmware and embedded system testing.
• Strong understanding of verification and validation methodologies.
• Experience with requirements-based testing.
• Experience with risk-based testing.
• Ability to build and maintain requirements traceability matrices.
• Hands-on testing experience with embedded devices and firmware-controlled products.
• Knowledge of I2C and SPI communication protocols.
• Experience with hardware/software integration testing.
• Experience working within a regulated environment.
• Experience creating and maintaining DHF documentation, Verification Plans, Test Protocols, and Test Reports.
• Strong documentation and technical writing skills.

Additional Skills & Qualifications

• Class II or Class III medical device experience.
• FDA submission support experience.
• Pump-based medical device experience.
• Electromechanical device experience.
• Exposure to automation testing frameworks.
• Experience scaling verification processes or teams.

Work Environment

This position is located onsite in Maple Grove, MN, with an expected presence of 3-4 days per week. The role offers 10 days of PTO and 10 paid holidays. This is a high visibility role during a critical product milestone, providing the opportunity to make a direct impact on a Class III life-sustaining medical device. You will have the ability to help build a verification organization as the team expands and have strong cross-functional exposure to Firmware, Systems, Quality, and Regulatory teams. The role offers the chance to influence process improvements and testing strategy. Job Type & Location, Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.