Lead Software Test Engineer

About the position

Nia Therapeutics is developing brain stimulation devices to restore memory function after brain injury and degenerative disease. Our team includes leaders in the fields of engineering, cybersecurity, neuroscience, and neurosurgery, and our core technology has the potential to revolutionize the treatment of patients with memory loss. We are seeking a highly motivated and experienced Lead Software Test Engineer to join our growing engineering team in Allston, MA. In this critical role, you will be responsible for ensuring the quality and reliability of our medical device software products through rigorous testing. You will be developing, executing and maintaining tests for a diverse and exciting technology stack, encompassing implantable and wearable device firmware, clinical and mobile software frontends, and a cloud-based backend.

Responsibilities

• Design, develop, and execute comprehensive test plans and test cases based on product requirements, design specifications, risk assessments, and FDA regulations ensuring compliance with relevant medical device standards and regulations (ISO 13485, IEC 62304, etc.).
• Develop and maintain automated test scripts and frameworks to improve test efficiency and coverage across all software components.
• Perform various levels of testing, including functional testing, system testing, integration testing, performance testing, and usability testing, focusing on Design Verification Testing (DVT) requirements.
• Set up and maintain test environments including hardware and software configurations, simulations, and emulators as needed.
• Analyze test results, identify defects, and document findings clearly and concisely in an issue tracking system.
• Collaborate closely with software developers, system engineers, regulatory affairs, and clinical teams to understand requirements, resolve issues, and ensure product quality.
• Participate in design reviews, requirement reviews, and risk assessments to provide testing perspectives and contribute to early quality assurance.
• Contribute to the continuous improvement of testing processes and methodologies within the organization.
• Stay up-to-date with the latest testing techniques, tools, and industry best practices, particularly in the medical device domain.

Requirements

• Bachelor’s degree in computer science AND 5+ years in software testing OR master’s degree in computer science AND 2+ years in software testing.
• Proven experience in Design Verification Testing (DVT) within a regulated industry, ideally medical devices or other safety-critical domains.
• Strong understanding of software testing methodologies and the software development lifecycle (SDLC).
• Experience testing across a full technology stack, including firmware testing (embedded systems, real-time operating systems preferred), desktop application testing (Windows-based applications), mobile application testing (iOS and/or Android), and backend/cloud system testing (AWS, Azure, GCP or similar).
• Software development experience (e.g., Golang, C, Python).
• Proficiency in test automation frameworks and tools (e.g., Selenium, Appium, Cypress, Robot Framework, etc.).
• Familiarity with test management tools and defect tracking systems (e.g., GitLab, Jira, TestRail, ALM).
• Excellent analytical and problem-solving skills with a strong attention to detail.
• Strong communication and interpersonal skills with the ability to collaborate effectively in a team environment.
• Ability to work independently and manage multiple tasks concurrently.

Nice-to-haves

• Solid understanding of medical device regulations and standards (ISO 13485, IEC 62304, FDA regulations - 21 CFR Part 820 is a plus).
• Experience with performance testing and security testing.
• Experience with CI/CD pipelines and automated testing integration.
• Knowledge of communication protocols used in medical devices (e.g., BLE).
• Test tool validation.
• Experience with requirements management tools.