Senior Software Quality Engineer

Job Description Summary The Senior Software Quality Engineer is accountable for supporting the Research Centre Ireland (RCI) site, RCI Project teams and/or other projects intended to enhance RCI's operational effectiveness, including the initial creation of a Quality Management System for the RCI site. The Sr. Quality Engineer focuses on the creation of quality processes and procedures at the RCI site which support design control, process control & validation, supplier management and technology transfer based on industry and BD best practices. Job Description We are the makers of possible 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. Why join us? A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. Become a maker of possible with us Our vision for Peripheral Intervention at BD Our Peripheral Intervention (PI) business unit offers a comprehensive range of medical products, devices and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance. About the role The Senior Software Quality Engineer plays a pivotal role as an emerging Subject Matter Expert within cross-functional project teams, particularly in areas such as new product development, manufacturing transfer, and special initiatives. This role ensures that software-related deliverables meet customer expectations and comply with a wide range of regulatory standards, including 21CFR820, 21CFR11, ISO 13485, ISO 14971, IEC 62304, IVDD 98/79/EEC, and EU MDR 2017/745. The engineer is responsible for guiding computer system validation efforts and assessing compliance with electronic records regulations, while also overseeing key quality processes such as design planning, risk management, design reviews, and change control for both application and embedded software. In addition to regulatory and project responsibilities, the Senior Software Quality Engineer reviews and approves critical documentation, including product drawings and verification/validation protocols. They apply statistical tools to analyse data, identify root causes, and drive effective problem resolution. Their expertise ensures that software products are developed and released with robust quality assurance, aligning with both internal standards and external regulatory requirements. This role is essential for maintaining product integrity and supporting continuous improvement across software development and quality functions. Main responsibilities will include: Develop, enhance and maintain strategies and plans to improve the overall quality of software, including test coverage and system performance. Provides strategic and tactical support of the Quality Engineering Function, based on an understanding of 21 CFR Part 820 and ISO Requirements. Owns and facilitates the Design Review and Functional Review Process for software products. Collaborates with Manufacturing and R&D to support software products, driving design improvements and monitoring measurable enhancements. Routinely interacts with multifunctional groups. Ensures BD PI Systems divisional, departmental policies, procedures, practices, and facilities are in compliance with all applicable regulatory guidelines. Represent the Quality Function for New Product Development Core Teams and/or Technology Transfer Core Team Plays a key role as a core team member in software development projects, handling various tasks such as requirements, SW development planning, risk management, V&V, and other work. Remediates software-related audit findings and CAPAs. About you Bachelor's degree in Electrical, Mechanical, Software or Biomedical Engineering or other relevant technical area with 6 to 7 years of experience, where 4 of those years are progressive experience in software development or lifecycle management. Or MS/MBA with 7 years of experience, where 5 of those years are progressive experience in software development or lifecycle management. Ability and skill to effectively manage multiple tasks and lead execution of change management plans Ability and skill to handle the Quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, Six Sigma root cause analysis tools and project management techniques Ability to effectively write communications that ensure clarity, accuracy and consideration of the audience Ability to speak with clarity and express points of view in a variety of settings: one-on-one interactions, group meetings, and formal presentations Ability to listen to others, including associates, managers, peers and customers, when making decisions and solving problems Ability and skill to analyse using systematic analysis tools that include root cause, failure analysis and risk assessment to gather critical information and diagnose Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO). Click on apply if this sounds like you At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.