Principal Software Test Engineer (Medical Devices)
Location: Plymouth, MN (Onsite)
Contract Duration: 6 months, possible extension
Pay Rate: $75/hr
**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