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.

To learn more about BD visit: https://bd.com/careers

Required Skills

Optional Skills

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Primary Work Location

IRL Wexford - Enniscorthy

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.

The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.

Salary Range Information

€54,800.00 - €83,600.00 EUR Annual

Design Quality Lead

Job Description