Senior Engineer I, Product Development
Confidential
- Wexford, Wexford, Ireland
- Wexford, Wexford, Ireland
About
Do you have the following skills, experience and drive to succeed in this role Find out below.
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.
Job Description As the Senior R&D Engineer you will work cross-functionally to lead research and development efforts of complex medical devices.
The position designs, develops and implements new products, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting.
Main responsibilities will include: Design: Design, develop and implement new products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings.
Make and present engineering decisions.
Participate and lead cross-functional teams in the design of a medical device.
Contribute ideas and/or generate intellectual property submissions.
Process Development: develop new processes by understanding key process inputs and outputs, using statistic methods such as DOE as appropriate.
Develop new process equipment and tooling, including specification development, vendor selection and negotiation.
Documentation: write and review product development plans, design reviews, technical documents and reports.
Prepare and approve verification and validation protocols and reports.
Develop and implement procedures/policy.
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: conduct engineering and competitor evaluations, and development unit testing.
Plan, develop, execute and manage verification and validation activities for new products and processes.
Training: train technicians and engineers on new design and process development as well as new test methods.
Supervisory/mentoring/coaching: Mentor and coach R&D technicians and engineers through New Product Development activities.
Fiscal: Creates, controls, manages a project budget (expense and/or capital expenditure).
Create and critique engineering cost analysis.
About you: B.S.
degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
Biomedical Engineering or Bioengineering degree preferred.
6+ 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 commercialization; ability to execute validation.
Ability to create and execute project plans and lead cross functional teams.
Basic tooling, design and drafting knowledge.
Excellent oral and written communication skills.
Ability to analyse data, interpret results, and write reports.
Proficient in statistic software.
Training in Six Sigma or Design for Six Sigma.
Knowledge of cGMP and GLP is a distinct advantage.
The salary range: €75,000
- €78,000 Click on apply if this sounds like you! Why Join Us? 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. xyswxtq
Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
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Languages
- English
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