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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.
As the R&D Engineer II, you will support in developing, optimising, implementing, and validating components/elements of a medical device. You will perform hands-on testing in optimisation of a device; conduct process development activities to understand process inputs and outputs; assist/write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations, and Regulatory Affairs.
Main responsibilities will include:
Design: Design components of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards. Build test parts for engineering evaluation, pre-clinical studies and clinical studies.
Process Development: assists in the development and optimization of processes to understand key process inputs and outputs, using statistic methods such as DOE as appropriate. Supports new process equipment and tooling development, including specification development, vendor selection and negotiation.
Documentation: prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications and drawings. Assist in preparing verification and validation protocols and reports.
Test Method Development: develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.
Testing: perform lab bench testing, conduct engineering and competitor evaluations, development unit testing, and execute verification and validation activities.
Training: train technicians on new design and process development as well as new test methods. Assist/conduct new process development training with operations and quality assurance.
Supervisory/mentoring/coaching: Mentor/coach R&D technicians through New Product Development activities like new process development, R&D materials/inventory control etc. May lead or manage technicians or engineering interns.
Other Responsibilities may include, however are not limited to:
Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
Assist in design and process root cause analysis and support non-conforming product and complaint investigations.
About you:
B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline with Biomedical Engineering or Bioengineering degree preferred.
Up to 3 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
Demonstrated hands-on technical aptitude.
Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialisation; ability to assist in executing validation.
Excellent oral and written communication skills.
Ability to work in cross functional teams.
Ability to analyze data, interpret results, and write reports.
The below skillset is a distinct advantage:
Proficient in statistic software is a plus.
Knowledge of cGMP and GLP is a plus.
Training in Six Sigma or Design for Six Sigma is a plus.
Click on apply if this sounds like you!
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
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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
€44,800.00 - €68,350.00 EUR Annual