Lead Software Test Engineer

Nia Therapeutics; Boston (MA); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An innovative company in the medical equipment sector is seeking a Lead Software Test Engineer to ensure the quality and reliability of cutting-edge brain stimulation devices. This role involves rigorous testing across a diverse tech stack, including firmware, mobile software, and cloud-based solutions. You will collaborate with multidisciplinary teams to maintain high standards of product quality while adhering to industry regulations. If you're passionate about making a difference in medical technology and have a strong background in software testing, this opportunity offers a dynamic environment to grow your career.

Qualifications

• 5+ years in software testing or 2+ years with a master's degree.
• Experience in Design Verification Testing (DVT) in regulated industries.

Responsibilities

• Design and execute comprehensive test plans based on product requirements.
• Develop and maintain automated test scripts to improve efficiency.

Skills

Software Testing

Design Verification Testing (DVT)

Analytical Skills

Problem-Solving

Communication

Teamwork

Education

Bachelor’s degree in Computer Science

Master’s degree in Computer Science

Tools

Selenium

Appium

Cypress

Robot Framework

Jira

TestRail

GitLab

Job description

Join to apply for the Lead Software Test Engineer role at Nia Therapeutics

Nia Therapeutics is developing brain stimulation devices to restore memory function after brain injury and degenerative disease. Our team includes leaders in engineering, cybersecurity, neuroscience, and neurosurgery, with core technology that could revolutionize treatment for memory loss.

We are seeking a highly motivated and experienced Lead Software Test Engineer to join our engineering team in Allston, MA. You will be responsible for ensuring the quality and reliability of our medical device software products through rigorous testing, including developing, executing, and maintaining tests across a diverse technology stack—implantable and wearable device firmware, clinical and mobile software frontends, and cloud-based backend.

Responsibilities

1. Design, develop, and execute comprehensive test plans and test cases based on product requirements, design specifications, risk assessments, and FDA regulations, ensuring compliance with standards like ISO 13485 and IEC 62304.
2. Develop and maintain automated test scripts and frameworks to improve testing efficiency and coverage.
3. Perform various testing levels, including functional, system, integration, performance, and usability testing, focusing on Design Verification Testing (DVT).
4. Set up and maintain test environments, including hardware/software configurations, simulations, and emulators.
5. Analyze test results, identify defects, and document findings clearly.
6. Collaborate with software developers, system engineers, regulatory affairs, and clinical teams to understand requirements, resolve issues, and ensure product quality.
7. Participate in design reviews, requirement reviews, and risk assessments to provide testing insights and contribute to early quality assurance.
8. Contribute to continuous improvement of testing processes and methodologies.
9. Stay updated with the latest testing techniques, tools, and industry best practices, especially in the medical device domain.

Education and Experience

1. Bachelor’s degree in computer science with 5+ years in software testing or master’s degree with 2+ years.
2. Proven experience in Design Verification Testing (DVT) within regulated industries, ideally medical devices.
3. Strong understanding of software testing methodologies and SDLC.
4. Experience testing across a full tech stack: firmware (embedded systems, real-time OS), desktop (Windows), mobile (iOS/Android), backend/cloud (AWS, Azure, GCP).
5. Software development experience (Golang, C, Python).
6. Proficiency with test automation tools (Selenium, Appium, Cypress, Robot Framework).
7. Familiarity with test management and defect tracking tools (Jira, TestRail, GitLab).
8. Excellent analytical, problem-solving, communication, and teamwork skills.
9. Ability to work independently and manage multiple tasks.

Preferred Qualifications

1. Knowledge of medical device regulations (ISO 13485, IEC 62304, FDA 21 CFR Part 820).
2. Experience with performance and security testing.
3. Experience with CI/CD pipelines and automated testing integration.
4. Knowledge of communication protocols like BLE.
5. Test tool validation and requirements management experience.

Location and Travel

This position is based in Allston, MA, with a hybrid schedule (4 days in-office). US work authorization required. No travel needed.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Industry: Medical Equipment Manufacturing