Job Description Summary
BD is in search of a talented R&D Senior Design Engineer looking to take their passion and experience with wearable infusion pumps, large volume injection devices, or the like to the next level into high volume manufacturing.
As a Senior Design Engineer with BD’s Pharmaceutical Systems team in Dublin, Ireland, you will have the opportunity to take a hands-on technical role on a cross functional project team developing the design, development, verification and validation of combination products in support of BD’s global R&D pipeline with special focus on the parenteral delivery of biologics and biosimilars. At its core, this role will give you the opportunity to develop user-centric drug delivery solutions designed to drive patient empowerment, independence, compliance, and improved health outcomes.
What you get to do every day:
- Develop & Deliver on new and exciting advanced drug delivery solutions as a Senior Design Development Engineer on a cross-functional project team through all phases of the project lifecycle, from concept through launch.
- Design, develop and verify complex products throughout the development life cycle.
- Translate business requirements into a robust, scalable technical design.
- Understand interactions between subassemblies in complex electromechanical systems, and design for high volume manufacturing for electro-mechanical medical devices.
- Pursue complex problems by applying sound engineering principles, utilizing experimental, computational and analytical methods to a range of technical product development challenges.
- Work closely with other R&D team functions, and external program functions to identify and mitigate technical issues to reduce programmatic risks.
- Lead structured problem solving and root cause investigations.
- Use predictive design and tolerance analysis techniques for calculation of design specifications.
- Develop and test prototypes.
- Design test equipment and create validated test procedures for product testing to demonstrate compliance with internal and external requirements such as ISO standards.
We are looking for a Senior Design Development Engineer who can:
- Work within multi-function teams comprising of QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members by facilitating effective communication and engagement.
- Lead activities such as bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications and component specifications.
- Apply and assert DFSS best practices on all projects
- Be an agile learner, tolerant of risk, and biased towards action
- Effectively and clearly communicate concepts, ideas and knowledge to other individuals, teams, leaders, and customers
- Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety laws, policies and procedures.
- Collaborate with manufacturing plants to assist in non-conformance issues with the products and identify creative solutions to problems in a timely manner to process ACR, and CAPA documents.
You will be effective if you have:
- Experience in developing/launching medical product(s) through a phase gate development cycle in an ISO13485 environment (or equiv.).
- Demonstratable knowledge in related technical fields
- Excellent analytical skills & discipline; able to conduct thorough analysis of concepts that have high uncertainty
- Intellectual drive to gain firsthand understanding of customer needs and impact to requirements
- Excellent critical thinking skills; able to constructively challenge ideas and invite critical feedback
- Ability to engage with a diverse, multi-national team to achieve a common vision
- Ability to build relationships; demonstrated facilitation skills across different functions; motivated by collective success
- Communicator able to translate complex technical concepts for non-expert audiences.
- History of working ith functional and project managers to identify and mitigate technical issues to reduce programmatic risks
- A propensity to quickly learn new concepts and technologies and convert them into customer solutions.
- The initiative to Identify innovation opportunities and drive continuous improvement efforts
- You will have a bachelor’s degree in Engineering, preferably in Mechanical, Biomedical, or Chemical Engineering.
- You will have experience leading small-medium size engineering teams.
- You will have experience with microfluidics / pump design.
- You will have experience in the design of complex electro-mechanical devices.
- Research post-graduate degree is also an advantage.
- You will have 7+ years’ experience in medical device design or R&D with a successful track record of delivering products to market and successfully supporting products in the market after launch.
- Ideally from a high volume manufacturing background.
- Knowledge of polymer material science and injection moulding processes and sustaining engineering activities post launch.
- You will have experience with Tolerance analysis. 2D drawing generation, GD&T and 3D CAD modelling.
- Statistical concepts such as those used in measurement system analysis, the design of experiments, and validation.
- You will be familiar with the stage gate processes and design controls used in medical product development and project planning and management of cross-functional teams.
The BD Difference
BD, founded in 1897, is a global medical technology company with over 40,000 associates in over 100 countries. We create specialized devices, solutions and systems to address many of the world’s most pressing healthcare needs. We operate under a single purpose: “to advance the world of health”.
We have been a strong employer presence in Ireland for the last 53 years. Join us and be our newest team member making the difference!
Primary Work Location
IRL BD and CO Dublin South