Firmware Test Engineer - Medical Device Verification Lead

Actalent; United States; Hybrid; USD 69,000 - 76,000; Full time

Benefits offered by this job

10 days PTO

10 paid holidays

Medical, dental & vision

401(k) Retirement Plan

Hybrid work environment

Job summary

Actalent is seeking a hands-on Firmware Test Engineer in Maple Grove, MN for a Class III medical device program. Lead verification testing, author plans, and ensure traceability from requirements to results.

This contract role involves regulatory readiness, risk-based testing, and collaboration with Firmware, Systems, Quality, and Regulatory teams. You will perform manual firmware and system-level testing, support FDA submissions, and help scale verification processes as the team grows.

Qualifications

• Experience with firmware and embedded system testing.
• Knowledge 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 with embedded devices and firmware-controlled products.
• Experience in a regulated environment.
• Experience creating DHF documents and test reports.

Responsibilities

• Execute firmware verification and validation activities for a regulated medical device.
• Review, update, refine, and execute verification plans and test protocols.
• Author and maintain Verification Plans, Test Protocols, Test Reports, and 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 on root cause analysis.
• Support commercialization activities and future remediation efforts.
• Contribute to scalable verification processes and team expansion.

Skills

Firmware testing

Embedded testing

Requirements-based testing

Risk-based testing

Traceability matrices

DHF documentation

Test Protocols

Documentation

I2C/SPI

Hardware/software integration

Regulated environment

Medical device experience

Tools

Automation testing frameworks

Job description

Actalent is seeking a hands-on Firmware Test Engineer in Maple Grove, MN for a Class III medical device program. Lead verification testing, author plans, and ensure traceability from requirements to results.

This contract role involves regulatory readiness, risk-based testing, and collaboration with Firmware, Systems, Quality, and Regulatory teams. You will perform manual firmware and system-level testing, support FDA submissions, and help scale verification processes as the team grows.