- Company Name
- Generis Tek Inc
- Job Title
- Principal Software Test Engineer
- Job Description
-
Job Title: Principal Software Test Engineer
Role Summary: Lead the design, development, and execution of the testing strategy for complex medical device software. Manage risk‑based verification, advanced test automation, and cross‑functional collaboration to ensure safety, reliability, and regulatory compliance across embedded, application, algorithmic, and cloud‑connected systems.
Expectations:
- Own and evolve the end‑to‑end verification architecture.
- Drive risk‑based testing and deep technical oversight without direct authority.
- Mentor and influence test engineers and other stakeholders to maintain high quality standards.
Key Responsibilities:
- Develop and execute comprehensive software testing strategies aligned with device requirements, risk controls, and regulatory expectations.
- Architect, build, and scale test automation frameworks supporting continuous integration and validation pipelines.
- Create, review, and maintain verification plans, protocols, test cases, and documentation for unit, integration, regression, interface, and system levels.
- Lead root‑cause analysis, defect triage, and resolution of software and system issues.
- Collaborate with engineering, quality, regulatory, and program teams to ensure verification deliverables meet schedules and compliance needs.
- Produce and sustain high‑quality verification documentation for design history files, audits, and regulatory submissions (e.g., FDA 21 CFR Part 820, IEC 62304, ISO 14971, IEC 60601‑1).
Required Skills:
- Proficiency in Python, C/C++, Java, or C# for test development and scripting.
- Deep understanding of embedded systems, real‑time OS, hardware/software integration, and software architecture.
- Expertise in risk‑based verification, test strategy, and automated testing frameworks.
- Experience with CI/CD pipelines (Jenkins, GitLab CI, etc.) and test automation integration.
- Strong analytical, problem‑solving, and documentation skills.
- Excellent communication and mentoring abilities; ability to lead by influence.
Required Education & Certifications:
- Bachelor’s or Master’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or a related technical field.
- 10+ years of experience in software testing, verification, or validation within medical device or regulated environments.
Minneapolis, United states
On site
Senior
09-03-2026