Senior R&D Engineer
Job ID: JOB-12236
Senior R&D Engineer
Ready to join one of the truly great companies in Ireland? We have a really exciting job opportunity for a Senior R&D Engineer based in Galway. Join a super team of people and a company that offers exceptional salaries and rewards. Let’s have a conversation to find out more about what’s important to you.
A DAY IN THE LIFE OF:
• 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.
• Interact 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).
- Master’s degree.
- 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).
• 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 more information on this Senior R&D Engineer position, get in contact with Shannon McCrossan on 086-8168273 or firstname.lastname@example.org
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