Title: Sr. Project Manager/ Principal Software Test Engineer
Duration: 12+ months contract
Location: 5050 Nathan Lane N. Plymouth, MN 55442
Job Summary
The Principal Software Test Engineer leads the design, development, and execution of the software testing strategy for complex medical device systems. This role is responsible for ensuring that all software whether embedded, application‑level, algorithmic, or cloud‑connected and meets the highest standards of safety, reliability, and regulatory compliance. The Principal Software Test Engineer functions as a technical authority in software verification, guiding cross‑functional teams in risk‑based testing approaches and advanced test automation. This role influences technical direction without direct authority, partnering closely with Software Engineering, Systems Engineering, Quality, and Regulatory to ensure robust and compliant product development.
Key Responsibilities
Testing Strategy & Leadership
* Lead the development and execution of the overall software testing strategy for medical device products, ensuring alignment with system requirements, risk controls, and regulatory expectations.
* Drive risk‑based verification activities to ensure high‑risk features and failure modes receive appropriate coverage and depth.
* Own and maintain the verification architecture across software, hardware, and integrated system components.
Test Frameworks & Automation
* Architect, build, and scale advanced test automation frameworks to support continuous integration and continuous validation activities.
* Develop automated test solutions for unit, integration, regression, interface, and system‑level testing.
* Evaluate and introduce new test tools, technologies, and methods to increase efficiency, coverage, and product quality.
Technical Execution
* Design and execute verification plans, protocols, and test cases—including both manual and automated approaches.
* Review test plans, automation scripts, and documentation created by other engineers to ensure consistency, completeness, and technical accuracy.
* Lead root‑cause investigations, defect triage meetings, and resolution activities for software and system‑level issues.
Cross‑Functional Collaboration
* Work across engineering, quality, regulatory, and program teams to ensure verification deliverables are aligned with product goals, schedules, and compliance needs.
* Serve as a technical mentor to test engineers, providing coaching on test design, automation, documentation practices, and risk‑based reasoning.
* Communicate verification status, risks, and readiness with clarity to both technical and non‑technical stakeholders.
Compliance & Documentation
* Ensure all verification activities meet medical device software regulations and standards, including (but not limited to):
o FDA 21 CFR Part 820
o IEC 62304
o ISO 14971
o IEC 60601‑1 and related standards
* Produce and maintain high‑quality verification documentation that supports design history files, audits, and regulatory submissions.
Required Qualifications
* Bachelor’s or Master’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related technical field.
* 10+ years of experience in software testing, verification, or validation for embedded, application‑level, or medical device software.
* Expertise in developing test strategies, frameworks, and automation solutions for complex, multi‑component systems.
* Strong programming/scripting skills (e.g., Python, C/C++, Java, C#, or similar).
* Deep understanding of software architecture, embedded systems, real‑time operating systems, and hardware/software interactions.
* Demonstrated experience working within regulated environments (medical device preferred).
* Proven ability to mentor engineers and influence cross‑functional teams without direct authority.
Preferred Qualifications
* Experience with CI/CD pipelines and test automation within Jenkins, GitLab, or equivalent environments.
* Hands‑on experience testing hardware‑integrated systems, firmware, sensors, or signal‑processing algorithms.
* Familiarity with cybersecurity testing, reliability testing, or networked medical device systems.
* Advanced experience authoring verification protocols, traceability matrices, and regulatory documentation.
Soft Skills & Leadership Attributes
* Strong analytical and problem‑solving abilities.
* Clear communicator capable of breaking down complex technical topics for diverse audiences.
* Highly organized, documentation‑driven, and detail‑oriented.
* Collaborative mindset with demonstrated ability to lead through influence.
* Passionate about safety, reliability, quality, and excellence in medical device engineering.
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