Job Title: Senior Experimental Design Specialist
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Job Description: Our organization is seeking a highly skilled Senior Experimental Design Specialist to join our team. This role will be responsible for developing and executing complex experimental designs, including animal studies and bench testing, to generate evidence for regulatory and clinical acceptance. The ideal candidate will have a strong background in biomedical engineering or a related field, with at least 6-10 years of experience in experimental design within the medical device industry.
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Responsibilities:
* Develop and execute experimental designs for animal studies and bench testing.
* Collaborate with cross-functional teams to ensure that experimental designs meet regulatory and clinical requirements.
* Evaluate new and current animal labs, and become point of contact for logistics and communication.
* Identify and contract neuro-interventionalists with animal intervention background to perform procedures.
* 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.
* Develop a mechanism to receive all requests for preclinical testing involved in characterising the limits of a product in development, generating evidence for additional regulatory questions beyond the initial launch in primary country, or for marketing claims to show competitive advantage for products in development or already launched.
* Ensure documentation to appropriate standards and responsible for managing the documents through the Quality System.
* Participate in new product development as a core team member representing preclinical strategy.
* Evaluate the appropriateness of questions in the voice of customer (VOC) and interpret their answers for the benefit of the team.
* Identify and manage key preclinical risks throughout the product lifecycle.
* Effectively collaborate with external collaborators, such as academic, Contract Research Organizations (CRO), and biotech partners.
Required Skills and Qualifications:
* Bachelor's degree in Biomedical Engineering, Biological Sciences, or related medical/scientific field.
* Advanced scientific degree (Masters or PhD) in an experimental design field, or equivalent experience.
* Minimum 6-10 years of experience in experimental design within the medical device industry.
* Strong design and technical ability based on broad and deep knowledge of fundamental scientific principles.
* Data review and statistical methods skills.
* Excellent writing, presentation, and verbal communication skills.
* Awareness of Good Laboratory Practices, the Animal Welfare Act, and all other applicable regulations.
About Us:
We are a leading organization in the medical device industry, dedicated to providing innovative solutions to improve patient outcomes. We offer a dynamic work environment, opportunities for professional growth and development, and a competitive compensation package.