Firmware Test Engineer

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

Job Title: Firmware Test Engineer

Job Description

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.

Essential Skills

• 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

This is a Contract position based out of Maple Grove, MN.

Pay and Benefits

The pay range for this position is $50.00 - $55.00/hr.

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.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Maple Grove,MN.

Application Deadline

This position is anticipated to close on Oct 9, 2026.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.