Principal Engineer, Software Quality



 We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 Job Description As the Principal Engineer in Software Quality , 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.

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). Lead review from Quality perspective for design, development, and execution of comprehensive test plans, test cases, and automation scripts for complex software systems, including embedded, application, and cloud-based solutions. Extensive knowledge of 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. Perform root cause analysis for software defects and collaborate with development teams to implement effective corrective and preventive actions. Drive continuous improvement initiatives in software quality processes, tools, and metrics, leveraging industry standards (e.g., ISO 13485, IEC 62304, FDA 21 CFR Part 820). Understanding of complaint handling process, metrics and product risk assessment 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. 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. Provide technical leadership and mentorship to junior quality engineers, fostering a culture of quality and continuous learning. Experience with Polarion ALM system is a plus Comfortable presenting to upper management Job Qualifications Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field. Minimum of 10 years of experience in software quality assurance or software engineering, with at least 5 years in a lead or principal role. 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. 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. Why