Firmware Verification Engineer for Class III Medical Devices

Pentangle Tech Services | P5 Group; Minnesota; On-site; USD 95,000 - 135,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Minnesota is seeking a hands-on Firmware Test Engineer to own verification and validation activities for a Class III medical device program.

The role involves developing, executing, and maintaining firmware verification testing, ensuring requirements traceability, supporting regulatory submissions, and driving testing efforts during the final stages of product development, in an onsite lab in Maple Grove, MN.

Qualifications

• Hands-on firmware and embedded systems testing experience.
• Experience with verification and validation methodologies.
• Ability to translate requirements into test cases and protocols.
• Experience with risk-based testing in regulated environments.
• Ability to build traceability matrices linking requirements, tests, and results.
• Experience with DHF documentation and audit-ready records.
• Familiar with medical device verification documentation requirements.
• Experience with firmware verification and validation in embedded systems.

Responsibilities

• Execute firmware verification and validation for a regulated Class III medical device.
• Review and implement verification plans and test protocols for coverage and compliance.
• Author and maintain verification plans, test reports, and DHF documentation.
• Establish requirement-to-test traceability and maintain traceability matrices.
• Perform manual firmware and system-level testing in a lab environment.
• Conduct requirements-based and risk-based testing aligned with standards.
• Participate in risk assessments and mitigation activities.
• Support FDA submission readiness and regulatory documentation.
• Investigate test failures with firmware/engineering teams for root cause analysis.
• Contribute to scalable verification processes and templates.

Skills

Firmware testing

Embedded systems

Verification and validation

Requirements traceability

Regulatory compliance

Risk-based testing

Test protocols

DHF documentation

FDA submission support

Tools

Embedded testing software

Job description

Pentangle Tech Services | P5 Group in Minnesota is seeking a hands-on Firmware Test Engineer to own verification and validation activities for a Class III medical device program.

The role involves developing, executing, and maintaining firmware verification testing, ensuring requirements traceability, supporting regulatory submissions, and driving testing efforts during the final stages of product development, in an onsite lab in Maple Grove, MN.