Senior Software Test Engineer en BrioHealth Solutions, Inc

About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.

Job Description

BrioHealth Solutions, Inc. is seeking a Senior Software Test Engineer to join our innovative R&D team. The ideal candidate will bring deep expertise in software testing – particularly in embedded systems and medical device software – and a strong command of modern test frameworks.

This role is perfect for someone passionate about software quality and the craft of testing: a person who is driven to ensure high-quality, reliable software through creative, technically sound, and regulatory-compliant test strategies. Your work will help ensure our products not only meet rigorous regulatory standards but also excel in real-world reliability, diagnosability, and performance.

As a Senior Software Test Engineer, you will play a key role in automated device verification, supporting the development of our BrioVAD implantable heart pump and other mechanical circulatory support (MCS) technologies. This is a broad and collaborative role, working cross-functionally with hardware and systems engineering, quality assurance, and regulatory affairs teams to deliver robust and reliable software test solutions.

Reports to: Senior Manager, Software Engineering

Location: Burlington, MA

Responsibilities

· Design, develop, and execute both manual and automated test plans for embedded and application-level software, ensuring the functionality, performance, and reliability of Class II and III medical devices in accordance with defined software requirements.

· Create and maintain comprehensive test documentation – including test plans, test cases, test scripts, and test reports – ensuring traceability, reproducibility, and full test coverage in compliance with medical device regulations (e.g., IEC 62304, ISO 13485).

· Collaborate closely with developers, product managers, clinical teams, and other stakeholders to understand product requirements and real-world usage scenarios. Partner with software and systems engineers to ensure seamless integration and thorough end-to-end testing of both software and hardware components.

· Develop and maintain automated test frameworks using Python, C#, or Java, with an emphasis on automation, CI/CD integration, and release reliability. Incorporate test automation into CI/CD pipelines using GitHub Actions or similar tools.

· Support device verification activities, ensuring all software components meet design specifications and regulatory standards. Lead test strategy planning for complex features and product releases.

· Contribute to post-release support efforts, including debugging, enhancing system diagnosability, and improving observability of software. Participate in risk assessments, root cause analyses, and CAPA (Corrective and Preventive Action) investigations related to software issues.

Requirements

· Bachelor’s degree in Electrical Engineering, Software Engineering, Computer Science, or equivalent professional experience.

· 5+ years of software testing experience, including at least 3 years in the medical device industry. Proven ability to test embedded software and applications in regulated environments.

· Proficient in coding and scripting with C/C++, C#/Java, and Python.

· Strong understanding of testing methodologies, including unit, integration, system, and acceptance testing.

· Familiarity with observability tools, logging systems, and post-deployment debugging techniques. Experience with Infrastructure as Code (IaC) tools such as Terraform.

· Hands-on experience with CI/CD tools like GitHub Actions, Jenkins, or Azure DevOps.

· Experience with test automation frameworks for Windows applications and/or mobile apps (e.g., Appium, WinAppDriver).

· Working knowledge of AWS or Azure, especially in deployment, logging, and monitoring.

· Strong analytical and problem-solving skills, including the ability to diagnose root causes and make sound technical decisions. Capable of viewing issues from both user and engineering perspectives.

· Excellent interpersonal and communication skills; able to collaborate closely with software engineers and other stakeholders, and to explain technical concepts to both technical and non-technical audiences.

· Proficient in technical writing and documentation to support audits, regulatory compliance, and traceability requirements.