Principal Software Test Engineer

Principal Software Test Engineer (Medical Devices)

Location: Plymouth, MN (Onsite)
Pay Rate: $75–78/hour
**Must be able to work on a W2**

Overview:
We are seeking a senior-level Software Test Engineer to lead verification and validation activities for complex medical device software systems. This role focuses on hands-on software testing, verification documentation, and cross?functional coordination to support a near-term software release in a regulated environment.

This is not a software development role. The ideal candidate brings deep experience in medical device software testing, strong documentation skills, and the ability to lead testing efforts without direct authority.

Key Responsibilities

• Lead and coordinate software verification and validation activities for embedded and system-level medical device software
• Execute risk-based testing aligned to system requirements and regulatory expectations
• Develop and execute verification plans, protocols, and test cases (primarily manual, hardware-integrated testing)
• Review and improve test documentation, including requirements, verification reports, and traceability
• Support defect investigation, triage, and resolution in collaboration with R&D
• Coordinate testing logistics, including hardware availability and dry runs
• Partner closely with Regulatory, Quality, and Engineering teams to ensure compliance and readiness
• Communicate testing status, risks, and issues clearly to cross-functional stakeholders
• Mentor and guide other engineers on test practices and documentation standards

Required Qualifications

• Bachelor’s or Master’s degree in Engineering, Computer Science, or related technical field
• 10+ years of experience in software testing, verification, or validation (medical devices strongly preferred)
• Senior-level experience leading or coordinating test efforts
• Strong background in regulated environments (IEC 62304, FDA-focused development)
• Excellent documentation skills (requirements & verification)
• Ability to read and understand code (C/C++ preferred) for debugging and test context
• Strong communicator able to work independently and influence cross-functional teams

Preferred Experience

• Medical device or pharmaceutical software testing
• Embedded systems, hardware?integrated testing, or Linux-based systems
• Exposure to IEC 62304 software lifecycle processes
• QT/QML familiarity
• Experience working directly with Regulatory teams