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.
Position Summary (Why this role matters):
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.
Key Responsibilities (What you'll do):
- 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
Qualifications and Skills:
- 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; experience testing medical device instrumentation and analysis software is preferred
- 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
Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position.
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