Design Quality Engineer Ii

Job Description Summary The Design Quality Engineer assures that new product designs and the processes for manufacturing them meet all local, corporate and divisional requirements with respect to safety and efficacy.
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 Quality at BD In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients.
About the role This role centers on ensuring quality and risk management throughout the lifecycle of new product development (NPD) projects.
The individual represents quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation.
They are responsible for reviewing design compliance, conducting statistical analyses (e.g., DOE), and initiating corrective actions when necessary.
The role also involves supporting biocompatibility testing aligned with ISO10993, participating in internal and supplier audits, and validating test methods and measurement systems like Gauge R&R.
Candidates for this position should possess a third-level qualification in engineering, science, or a technical field, along with a minimum of five years of experience in the medical device or pharmaceutical industries.
A solid understanding of regulatory standards, including ISO 13485, ISO 14971, and related CFRs, is essential.
Preferred skills include attention to detail, adaptability, strong problem-solving abilities, and excellent interpersonal skills.
The role requires someone who can manage multiple projects independently while collaborating effectively in team settings and meeting deadlines consistently.
Main responsibilities will include: Represents quality interests and concerns on project teams.
Leads risk management activities and owns the Quality engineering activities for NPD projects.
Must be able to balance multiple projects and tasks, from product inception through product launch and maintenance.
Review design control compliance requirements for NPD projects and all design elements.
Is responsible for the development of the UFMEA & DFMEA, coordinating guidance from the other design sub-team members and supporting the development of the PFMEA.
Performs DOE's and other statistical analysis to support product and process optimisation or resolve causes of process variation.
Initiate corrective actions as required.
Supports assessment of Biocompatibility testing required as per ISO10993 and company procedures.
Participates in internal audit and supplier audit programmes.
Risk management - U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation.
About you Third-level Engineer / Technical / Science Qualification Minimum of 5 years in the medical device or pharmaceutical industry is desirable Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR. Attention to detail and adaptability Dedication to excellence, flexibility Problem-solving techniques with excellent organization skills Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to target and deadlines Click on apply if this sounds like you
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate on the basis of 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, or any other protected status.