We are seeking an accomplished professional to fill a challenging role in preclinical research. The successful candidate will be responsible for leading complex experiments, including protocol development, report writing, and presentations.
About the Role
This position requires a strong background in biomedical engineering, biological sciences, or a related field, with a minimum of 6-10 years' experience in experimental design within the medical device industry. Prior experience developing animal study protocols is also essential.
Key Responsibilities
* Acquire an in-depth knowledge of current products in development from a technical and usability point of view.
* Serve as study sponsor representative for animal experiments, accountable for concept to completion of the studies.
* Evaluate new and current animal 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.
* Effectively work with NTI, our advanced science and modelling group, to coordinate and utilise the NTI lab, models and technologies for related bench testing.
* Develop and implement highly complex experiments, including deep dives on the technical feasibility or test-to-failure experiments.
* Utilise exposure to clinicians to identify areas of unmet need and innovate new solutions.
* Participate in new product development as a core team member, representing physician needs and practical use.
* Participate in Target Product profile (TPP) generation, bringing physician needs and preclinical testing experience to drive align TPPs with areas of greatest need.
Requirements
* Honours degree in Biomedical Engineering, Biological Sciences, or related medical / scientific field.
* A minimum of 6-10 years' experience in experimental design within the medical device industry.
* Prior experience developing animal study protocols.