Job Description
An experienced Principal Scientist is required by Careerwise recruitment to work with a Galway life sciences multinational on a 12 months contract.
Role of this position
1. Evaluate new and current labs, become point of contact for logistics and communication.
2. In collaboration with Regulatory, develop and maintain an inventory of Notified Body requirements and responses over the years for animal testing.
3. 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.
4. 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.
5. 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.
6. Utilise exposure to clinicians to identify areas of unmet need and utilise this information to innovate new solutions.
7. Participate in new product development as a core team member, representing physician needs and practical use. Practical problem solving required.
8. Participate in Target Product Profile (TPP) generation, bringing physician needs and preclinical testing experience to drive align TPPs with areas of greatest need.
9. Identify and manage of key preclinical risks throughout the product lifecycle.
10. Ensure documentation to appropriate standards and responsible for managing the documents through the Quality System.
JOB REQUIREMENTS
11. Honours degree in Biomedical Engineering, Biological Sciences, or related medical / scientific field.
12. A minimum of 6-10 years' experience in experimental design within the medical device industry.
13. Prior experience developing animal study protocols.
14. Strong design and technical ability based on a broad and deep knowledge of fundamental scientific principles.
15. Excellent writing, presentation, and verbal communication skills essential.