About the Role

We are looking for a Research Scientist to join our team. This Research Scientist will work closely with project teams and the Biosciences team to:  identify appropriate existing nonclinical (in vivo, in vitro, and ex vivo) testing methods; support existing nonclinical laboratory-based testing methods; facilitate the development and implementation of new nonclinical models and testing methods; and understand and evaluate device application and performance.

This position will be located at our facility in Flagstaff, Arizona, with the possibility of a hybrid work arrangement.

Responsibilities

• Collaborate with business groups, project teams and subject matter experts to develop scientifically rigorous nonclinical studies, including good laboratory practice (GLP) compliant nonclinical studies to evaluate medical device safety and performance
• Provide scientific guidance, review and support for nonclinical studies
• Develop and refine nonclinical models for evaluation of medical technologies
• Support activities related to the submission of nonclinical studies to regulatory agencies
• Generate reference documents, contributing scientist reports and standard operating procedures
• Mentor associates on the appropriate utilization of animal models with respect to ethical utilization (Animal Welfare Act) and clinical relevance
• Maintain an understanding of the trends in the medical device industry and current state-of-the-art methods for the evaluation of device safety and efficacy
• Maintain compliance with training expectations as required for this position
• Evaluate, prepare, handle, and analyze explanted articles, including biohazardous materials, with appropriate associates as part of a device evaluation process
• Perform additional responsibilities as required within the scope of position

Required Qualifications

• Bachelor’s degree in Anatomy, Life Sciences, Biomedical Sciences, Biomedical Engineering or another relevant field
• Minimum 5 years of experience with nonclinical testing of medical devices
• Experience creating and using nonclinical models, including biosimulators and ex vivo models
• Demonstrated strong communication skills in order to educate and influence people from a broad range of disciplines
• Demonstrated strong scientific rigor with ability to critically review literature, analyze data, write scientific reports and to provide scientific guidance
• Ability to design experiments to deliver results in support of achieving needs of a project team
• Ability to support multiple initiatives or projects simultaneously
• Ability to travel 10%

Desired Qualifications

• Master’s degree or Ph.D. in Anatomy, Life Sciences, Biomedical Sciences, Biomedical Engineering or another relevant field, or DVM
• Hands-on experience with cadaveric models in the testing of medical devices
• Experience in evaluating explanted medical devices in the context of identifying possible device or material issues

This position offers a hybrid work arrangement in the country from which the Associate is employed.  Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.