An exciting opportunity has arisen for an experienced Senior R&D Engineer to join a leading, multi-national medical device company in Galway on a permanent basis. The successful applicant will gain extensive exposure to both the product and the wider team, working cross functionally to develop life changing, structural heart products.
As a Senior R&D Engineer, you will be a highly experienced professional in engineering development and have extensive engineering knowledge and skills. You will be a dynamic team player and will work cross functionally with a variety of teams.
- Lead the development (design and process) of PTA balloons in the Peripheral Vascular space.
- Assist in the development of new combination products and components.
- Prototype, test, and iterate designs used in the medical field.
- Leading teams of design engineers during development of products.
- Support the development and integration of new technologies into the Cardiovascular product offering.
- Provide assistance to interdepartmental team for new product introduction.
- Take an active role in early-stage design control activities leading to a first in man study (innovation, proof of principle, product development, process development, and equipment development) such that a robust pilot line that is scalable and transferable to commercial manufacturing is achievable.
- Document research and development process through lab notebooks, engineering characterization studies, and test reports.
- Work with Regulatory Affairs (RA) to compile US and OUS regulatory submissions. Assist RA with answering subsequent questions from regulatory bodies.
- Design and develop new test methods and equipment specific to new products. Train technicians in new processes.
- Create document change orders (CO’s) for design, materials, and process documentation.
- Work with Regulatory, Preclinical, Quality, and Manufacturing departments to create product performance, design, and manufacturing specifications.
- Perform competitive product analyses.
- Work with patent counsel to file and evaluate intellectual property.
- Ieract frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.
- Minimum travel requirement of 10%.
- Bachelor’s Degree in Engineering (Materials, Mechanical or Biomedical).
- 6+ years working in R&D, Quality and/r Manufacturing on combination medical devices.
- Experience with test method validation.
- Mechanically drive design experience.
- Knowledge of design of experiments (DOE) and statistical techniques.
- Proficient with SolidWorks.
Key Skills and Experience
- Specialized knowledge in PTA balloon design and process development (extrusion, forming) is essential.
- Experience in R&D, Quality and/or Manufacturing in a regulated industry, working through different phases of product development.
- Leading teams / sub teams.
- Mentoring engineers.
- Prototyping mechanical systems.
- Complete understanding and wide application of technical principles, theories, and concepts toward product, process, and technology development and evaluation.
- Able to provide imaginative, thorough, and practical technical solutions to a wide range of difficult problems, consistent with company’s objectives.
- Successful collaboration as part of a cross-functional team.
- Background demonstrating strong self-motivation; able to works under only general direction, independently determining and developing approaches to solutions.
- Proficient with computer applications (i.e., Word, Excel, PowerPoint, Minitab, etc.).
- Ability to communicate well (both written and verbal).
For a more detailed and confidential discussion on this role contact Amy Newell.