
R&D Engineer II
- Limerick
- Contract
- Full-time
- Contribute to the design, development, and refinement of a next-generation aortic endovascular repair system.
- Support feasibility studies, prototype development, and functional testing.
- Assist in defining and executing verification and validation plans, ensuring compliance with regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820).
- Collaborate closely with cross-functional teams including clinical, regulatory, quality, and manufacturing.
- Participate in risk management activities, including FMEA and design hazard analysis.
- Document design controls in line with internal and external standards.
- Engage in iterative design processes using input from clinical experts, pre-clinical testing, and simulation data.
- Contribute to the preparation of technical documentation for regulatory submissions and design reviews.
- Stay abreast of emerging trends in endovascular technologies and aortic repair therapies.
- Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
- 1–5 years of experience in medical device design and development (preferably within cardiovascular or endovascular domains).
- Hands-on experience with CAD tools (e.g., SolidWorks) and rapid prototyping techniques.
- Understanding of anatomy and physiology relevant to vascular/aortic systems is a strong plus.
- Strong analytical and problem-solving skills with a creative, innovation-driven mindset.