Principal Scientist
- Galway
- Contract
- Full-time
- Evaluate new and current labs, become point of contact for logistics and communication.
- In collaboration with Regulatory, develop and maintain an inventory of Notified Body requirements and responses over the years for animal testing.
- Create a ‘test-to-fail’ strategy to conduct bench testing on products in development to characterise their limits from a usability point of view, using in-house physicians and engineers to perform the testing.
- Effectively work with our in-house advanced science and modelling group, to coordinate and utilise the lab, models and technologies for related bench testing, and provide input for improvement.
- Develop and implement highly complex experiments, including deep dives on the technical feasibility or test-to-failure experiments. Responsible for protocol development, report writing, and presentations to address the research or regulatory questions collaborating with R&D, Quality, and Regulatory for all experiments and relevant bench studies.
- Utilise exposure to clinicians to identify areas of unmet need and utilise this information to innovate new solutions.
- Participate in new product development as a core team member, representing physician needs and practical use. Practical problem solving required.
- Participate in Target Product Profile (TPP) generation, bringing physician needs and preclinical testing experience to drive align TPPs with areas of greatest need.
- Identify and manage of key preclinical risks throughout the product lifecycle.
- Ensure documentation to appropriate standards and responsible for managing the documents through the Quality System.
- A minimum of 6-10 years’ experience in experimental design within the medical device industry.
- Prior experience developing animal study protocols.
- Strong design and technical ability based on a broad and deep knowledge of fundamental scientific principles.
- Excellent writing, presentation, and verbal communication skills essential.