Salary
💰 $94,725 - $142,088 per year
Tech Stack
JenkinsPythonSDLC
About the role
- 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
- Software requirement analysis, architectural and design specification reviews, and creating use cases
- Identifying and filling gaps in Use Cases/Test Cases
- Creating and executing test plans, test designs and test cases and generating test reports
- Creating and updating trace matrices between requirements and tests
- Work closely with the software development team to identify improvements and influence requirements for testability
- Oversee and influence development of test objects to meet needs of protocol
- Develop and extend protocols and plans as device features evolve
- Participate in product design reviews and software tool validations
- Perform peer reviews, software hazard analysis, requirements traceability, code analysis, defect tracking, software metrics, and configuration management
- Mentor junior QA engineers and contribute to continuous improvement of QA processes
- Participate in Agile/Scrum ceremonies and contribute to sprint planning and retrospectives
- Coordinate daily stand-ups and syncs across onshore and offshore teams and establish handoff protocols, test ownership, and defect resolution workflows
Requirements
- 5+ years of experience in embedded software testing, with a strong mix of manual and automation
- At least 2+ years in medical device software testing
- Familiarity with SDLC, test lifecycle, and Agile methodologies
- Proficiency in Python, Jenkins, and test automation tools
- Experience working with products from the prototype through 510(k)/ISO clearance and commercialization (preferred)
- Thorough understanding of software quality assurance principles, practices and metrics
- Hands on experience using modern software development and quality assurance tools
- Proven record 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 (a plus)
- Strong analytical and problem-solving skills
- Excellent communication and documentation abilities
- Exposure to CI/CD pipelines and source control systems like Git
- Experience coordinating distributed QA teams, including offshore coordination and remote collaboration tools (Jira, Confluence, Slack, Teams)
- Leadership/interpersonal skills: Self-Motivated; Results-driven with ‘can-do attitude’; Proactive; Quick Learner
- Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Electrical Engineering, or related field