Software Development Test Engineer

HISTOSONICS•Plymouth, MN

13h•Onsite

About The Position

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties. We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most. The Software Development Test Engineer is a software engineer responsible for designing, building, and maintaining automated test frameworks and tooling that verify HistoSonics’ software throughout the development lifecycle. This role holds test code to the same engineering standard as production code, partners closely with development teams to build testability into the product from the start, and executes exploratory, integration, and verification testing where automation isn’t yet practical — while maintaining traceability from requirements through test evidence in support of HistoSonics’ quality and regulatory obligations.

Requirements

Bachelor’s degree in Computer Science, Math, Engineering, or a related field
2+ years of experience in Software Testing and/or other areas of the SDLC
Demonstrated software development experience in C#, Java, Python, or a similar object-oriented language, with the ability to design, build, maintain, and troubleshoot automated test frameworks and test tools
Experience with unit testing frameworks (e.g., NUnit, JUnit, or pytest) and automated test framework design
Experience with API, integration, UI, and system-level testing
Working knowledge of Windows operating systems, SQL Server, and performance/stress testing tools
Experience with Git (or similar source control systems), defect tracking tools, and CI/CD pipelines
Familiarity with IEC 62304, ISO 14971, and risk-based testing practices in regulated environments
Understanding of cybersecurity testing considerations for connected medical devices
Basic knowledge of electrical and mechanical engineering principles
Experience working in Agile/Scrum development environments
Strong analytical, organizational, and prioritization skills with attention to detail
Self-motivated team player who can manage multiple priorities, learn quickly, and collaborate effectively across disciplines

Nice To Haves

experience testing medical device instrumentation and analysis software is preferred

Responsibilities

Interact with product development teams to build a strong understanding of project and testing objectives
Partner with design and software teams to influence requirements and architecture for testability
Contribute to and extend automated test frameworks and reusable test infrastructure at the unit, API/integration, and system levels
Estimate, prioritize, plan, and coordinate testing activities within Agile/Scrum sprints and ceremonies
Create test plans and test cases based on requirements, and derive acceptance criteria with traceability back to requirements
Develop and execute automated and unit tests (e.g., using frameworks such as NUnit, JUnit, or pytest); analyze and report results
Write and review test code to the same design and quality standard as production code, using Git or other source-code control systems
Participate in design reviews and risk assessment meetings, applying risk-based testing principles consistent with ISO 14971
Set up test environments (hardware, software, and network)
Execute manual and automated tests against software releases, including basic security/cybersecurity test considerations consistent with FDA premarket cybersecurity expectations
Document, track, and manage defects through the defect tracking system
Troubleshoot and investigate root cause of defects with the design team, documenting findings per CAPA/nonconformance procedures
Perform thorough regression testing when defects are resolved
Track software quality assurance metrics, such as defect densities and open defect counts
Contribute to CI/CD pipeline integration for automated test execution
Ensure all applicable tasks are performed in compliance with the Quality Management System and relevant IEC 62304 software lifecycle requirements
Participate in continuous improvement of the Quality System, software development, and testing procedures