Want to know if this job is worth applying to?
IRL Wexford - Enniscorthy, Ireland
Onsite
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.
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.
This role support 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:
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 3+ years’ experience in Class II or Class III medical devices.
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
Salary Range €50K - €55K
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 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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
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.
Required Skills
Optional Skills
.
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
€56,600.00 - €86,300.00 EUR Annual