Job Description Summary 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 This role leads the Design Quality team at BD Enniscorthy, with primary responsibility for developing, maintaining, and governing the product risk management file, while providing comprehensive quality engineering support across new product development and product introduction activities. The position ensures full compliance with applicable regulatory requirements and BD procedures, and plays a key role in the planning, development, implementation, and ongoing support of projects, aligning quality objectives with site and organisational goals. Main responsibilities will include: Lead and manage Quality Engineering direct reports, including hiring, performance management, training, development, and corrective actions Ensure compliance with all applicable regulatory requirements, standards, and BD procedures Manage and allocate Quality Engineering resources for New Product Development (NPD) and New Product Introduction (NPI) programs Provide Quality Engineering support for test method validation, product verification and validation, reliability testing, and statistical data analysis Oversee component qualifications, process capability studies, equipment qualifications, and process validations Facilitate and ensure compliance with risk management activities, supporting NPD/NPI teams in generating and maintaining risk files Support field assurance investigations and post-market surveillance activities as required Collaborate closely with R&D and Engineering to enable successful execution of the product development lifecycle and robust product launches Review and approve validation documentation and risk management files; participate in regulatory, corporate, and third-party audits Support regulatory submissions, promote a positive teamwork culture, and contribute to additional projects as assigned About you Required Qualifications Third-level degree in Engineering, Science, or a related technical discipline Minimum of 5+ years' experience in Class II or Class III medical devices, with at least 3 years in a people-management or supervisory role Experience working in a highly regulated environment (medical device, pharmaceutical, or life sciences) Experience & Technical Expertise Strong knowledge of quality and regulatory standards, including QSR, ISO 13485, ISO 14971, MDD/MDR, MDSAP, 21 CFR, and applicable ICH guidelines Hands-on experience with design, process, equipment, test method, and software validation activities Proficiency in Quality Engineering tools such as risk management, root cause analysis, statistics, sampling plans, and process capability studies Experience supporting new product development and commercialization, including risk assessments and component qualification Proven experience conducting and supporting quality and regulatory audits Skills & Competencies Demonstrated ability to drive results, take ownership, and deliver high-quality outcomes in a fast-paced environment Action-oriented mindset with the confidence to make decisions amid complexity and ambiguity Strong customer focus, with the ability to build trusted relationships across internal and external stakeholders Excellent communication, presentation, and influencing skills at all organizational levels Collaborative team leader who promotes engagement, accountability, and continuous learning Strong analytical and problem-solving capabilities, with the ability to effectively prioritize and manage multiple demands Adaptable, self-motivated, and open to innovation and continuous improvement 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.
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