MedTech Software Test Engineer – Automation & QA

HISTOSONICS INC; Plymouth (MN); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Benefits package: health, dental, and

Job summary

HistoSonics is seeking a Software Development Test Engineer in Plymouth, MN to design, build, and maintain automated test frameworks for their Edison System. You will partner with development teams, implement testability from the start, and execute exploratory and automated tests to ensure software quality across the development lifecycle.

The role requires 2+ years in software testing, proficiency in C#/Java/Python, experience with NUnit/JUnit/pytest, and familiarity with Windows, SQL Server,

Qualifications

• 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.

Responsibilities

• Interact with product development teams to understand 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 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.

Skills

Software testing

C#

Java

Python

Unit test frameworks

API testing

CI/CD

Agile/Scrum

Windows

SQL Server

Git

Risk-based testing

Education

Bachelor's degree in Computer Science, Math, Engineering, or related field

Tools

JUnit

pytest

NUnit

Git

SQL Server

Job description

HistoSonics is seeking a Software Development Test Engineer in Plymouth, MN to design, build, and maintain automated test frameworks for their Edison System. You will partner with development teams, implement testability from the start, and execute exploratory and automated tests to ensure software quality across the development lifecycle.

The role requires 2+ years in software testing, proficiency in C#/Java/Python, experience with NUnit/JUnit/pytest, and familiarity with Windows, SQL Server,