Medical Device Software Testing Jobs in Boston, MA

Job Summary

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Position Overview: Insulet is seeking a highly skilled and detail-oriented Senior Software Test Engineer to lead testing efforts for embedded software systems in regulated medical devices. This role involves designing and executing both manual and automated test strategies to ensure compliance, safety, and performance of embedded applications across various platforms. The ideal candidate will have experience collaborating with onshore and offshore QA teams to drive global test execution and quality alignment.

Responsibilities:

• Develop and maintain manual and automated test cases for embedded software.

• Perform functional, regression, performance, stress, and reliability testing.

• Ensure compliance with industry standards and internal quality benchmarks.

• Maintain detailed documentation of test plans, procedures, and results.

• Conduct software requirement analysis, architectural and design specification reviews, and create use cases.

• Identify and fill gaps in use case/test case coverage.

• Create and execute test plans, test designs, and test cases, and generate test reports.

• Create and update trace matrices between requirements and tests.

• Collaborate closely with the software development team to identify improvements.

• Influence requirements definition and software design to maximize testability.

• Oversee and influence the development of test objects to meet protocol needs.

• Develop and extend protocols and plans as device features evolve.

• Participate in product design reviews.

• Mentor junior QA engineers and contribute to continuous improvement of QA processes.

• Participate in Agile/Scrum ceremonies and contribute to sprint planning and retrospectives.

Required Leadership/Interpersonal Skills & Behaviors

• Self-Motivated
• Results-driven with 'can-do attitude'
• Proactive
• Quick Learner

Required Skills and Competencies:

• 5+ years of experience in embedded software testing, with a strong mix of manual and automation, including at least 2+ years in medical device software testing.

• Familiarity with SDLC, test lifecycle, and Agile methodologies.

• Proficiency in Python, pytest, Jenkins, and test automation tools.

• Experience working with products from prototype through 510(k)/ISO clearance and commercialization is preferred.

• Thorough understanding of software quality assurance principles, practices, and metrics, as well as software development and testing best practices that foster high-quality software.

• Hands-on experience using modern software development and quality assurance tools.

• Proven record of developing and executing software test protocols for complex medical devices.

• Document test protocols, procedures, and results in accordance with design history file (DHF) and quality system documentation.

• Familiarity with IEC 62304, ISO 14971, FDA 21 CFR Part 820 standards, regulations, and international standards applicable to medical device software development, verification, and validation is a plus.

• Strong analytical and problem-solving skills.

• Excellent communication and documentation abilities.

• Exposure to CI/CD pipelines and source control systems like Git.

• Coordinate daily stand-ups and syncs across onshore and offshore teams using tools like Jira, Confluence, Slack, and Teams.

• Establish clear handoff protocols, test ownership, and defect resolution workflows across time zones.

• Foster a culture of transparency, accountability, and continuous improvement across global QA teams.

Education and Experience:

• Bachelor's degree required (preferred field of study in: Computer Science, Biomedical Engineering, or Electrical Engineering)

• 5+ years of experience in embedded software testing, with at least 2+ years in medical device software testing.

• Proven experience working with distributed QA teams, including offshore coordination and remote collaboration tools.

• Strong understanding of medical device regulations, including IEC 62304, ISO 14971, and FDA guidance.

• Exposure to CI/CD pipelines, Git, and DevOps practices is a plus.

Additional Information:

• Travel is estimated at 0% but will flex depending on business needs.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office). #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $97,100.00 - $145,700.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: Medical, dental, and vision insurance 401(k) with company match Paid time off (PTO) And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.