Job Description
Job Summary
As a Sr. Software Quality Engineer at Becton, Dickinson and Company, you will play a critical role in ensuring the quality and reliability of our medical device software. You will be responsible for defining, implementing, and executing robust quality assurance processes throughout the entire software development lifecycle, contributing to the delivery of safe and effective products that positively impact patient care.
Job Responsibilities
- Develop, implement, and maintain comprehensive software quality assurance strategies, plans, and procedures in accordance with industry best practices and regulatory requirements (e.g., FDA, ISO 13485, IEC 62304).
- Experience in being lead SWQA for new product development projects.
- Ability to understand software risks and develop risk management files for software and system level risk.
- Lead defect management and CCB meetings to review and disposition project defects
- Lead and participate in design reviews, code reviews, and other technical assessments to identify potential quality issues early in the development process.
- Understanding of test plans, test cases, and test scripts for various levels of testing, including unit, integration, system, and regression testing.
- Perform risk analysis and develop mitigation strategies for software defects and quality-related issues.
- Understanding of complaints process and metrics
- Collaborate closely with software development, project management, and regulatory affairs teams to ensure seamless integration of quality activities throughout the product lifecycle.
- Investigate, analyze, and document software defects, working with development teams to ensure timely resolution and verification.
- Contribute to the continuous improvement of software development processes and quality assurance methodologies.
- Participate in external and internal audits, providing documentation and expertise related to software quality.
- Stay current with emerging technologies, industry trends, and regulatory changes in medical device software quality.
Job Qualifications
- Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field. Master's degree preferred.
- 5+ years of experience in software quality assurance, with at least 2 years in the medical device industry or another highly regulated environment.
- Strong understanding of software development lifecycle (SDLC) methodologies (e.g., Agile, Waterfall) and their application in a regulated context.
- In-depth knowledge of relevant medical device regulations and standards, including FDA 21 CFR Part 820 (QSR), ISO 13485, and IEC 62304.
- Proven experience in designing, implementing, and executing various types of software testing.
- Proficiency with test management tools (e.g., Polarion, Jira, Azure DevOps) and defect tracking systems. Polarion knowledge is a plus.
- Experience with automated testing frameworks and tools (e.g., Selenium, Coded UI, Squish) is highly desirable.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong communication (written and verbal) and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
- Ability to work independently and as part of a team in a fast-paced, dynamic environment.
