Firmware Test Engineer

Pentangle Tech Services | P5 Group

Minneapolis (MN)

On-site

USD 85,000 - 110,000

Full time

3 days ago
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Job summary

Pentangle Tech Services | P5 Group in Minneapolis, MN is seeking a Firmware Test Engineer to lead verification and validation of a Class III medical device. This hands-on role focuses on ensuring device safety and regulatory readiness through lab-based testing of embedded systems.

You will develop verification plans, manage test protocols, maintain traceability, and collaborate with Firmware, Systems, Quality, and Regulatory teams to drive FDA submission readiness.

Qualifications

  • Firmware and embedded systems testing experience.
  • Background in verification & validation (V&V).
  • Requirements-based and risk-based testing experience.
  • Hands-on testing of embedded devices and system-level testing.
  • Experience with DHF documentation and traceability.
  • Experience in medical device or regulated industry.

Responsibilities

  • Lead firmware verification & validation efforts.
  • Execute requirements-based and risk-based testing.
  • Develop and maintain verification plans, protocols, and reports.
  • Build and manage requirements traceability matrices.
  • Perform hands-on testing of embedded systems and firmware-controlled devices in a lab environment.
  • Support FDA submission readiness and compliance documentation.
  • Troubleshoot test failures and partner with engineering teams on root cause analysis.
  • Collaborate closely with Firmware, Systems, Quality, and Regulatory teams.

Skills

Firmware testing
V&V
Requirements-based testing
Risk-based testing
Embedded systems testing
I2C & SPI
DHF documentation
Traceability
Regulated industry experience

Job description

Focus: Firmware Testing | Embedded Systems | Verification & Validation | FDA-Regulated Products

Want to work on technology that directly impacts patient lives?

I'm partnering with an innovative medical device team in Minneapolis, MN seeking a Firmware Test Engineer to support a critical Class III medical device program. This is a hands-on opportunity to drive verification and validation activities for a life-sustaining product as it moves through final development milestones and regulatory readiness.

What You'll Be Doing
  • Lead firmware verification & validation (V&V) efforts
  • Execute requirements-based and risk-based testing
  • Develop and maintain verification plans, protocols, and reports
  • Build and manage requirements traceability matrices
  • Perform hands-on testing of embedded systems and firmware-controlled devices in a lab environment
  • Support FDA submission readiness and compliance documentation
  • Troubleshoot test failures and partner with engineering teams on root cause analysis
  • Collaborate closely with Firmware, Systems, Quality, and Regulatory teams
What We're Looking For
  • Firmware and embedded systems testing experience
  • Strong background in verification & validation (V&V)
  • Requirements-based and risk-based testing experience
  • Hands-on experience with embedded devices and system-level testing
  • Knowledge of I2C and SPI communication protocols
  • Experience creating and maintaining DHF documentation
  • Requirements traceability and technical documentation expertise
  • Medical device or other regulated industry experience
Highly Preferred
  • Class II or Class III medical device experience
  • Pump, infusion, or life-sustaining device experience
  • Electromechanical systems testing experience
  • Exposure to test automation frameworks and verification strategies
  • Familiarity with IEC and ISO standards
Why This Opportunity Stands Out

This role offers the chance to work on a product that truly matters. You'll have visibility across the organization, influence verification strategy, and help ensure the safety and reliability of a life-sustaining medical device while contributing to the growth of a scalable verification organization.

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