Senior Software Test Engineer – Embedded Software, Manual & Automation

Role Overview

• 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.

Requirements

• 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.

Tech Stack

• Jenkins
• Python
• SDLC

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs