About the Role

We are looking for a Scientist to join our team. This 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 role will be located at our facility in Flagstaff, Arizona.

Responsibilities

• Collaborate with business groups, project teams and subject matter experts to develop scientifically rigorous nonclinical in vivo and in vitro 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 the position

Required Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Sciences, Biomedical Engineering or another relevant field
• Minimum of 2 years of experience performing nonclinical testing of medical devices in in vitro blood contact models
• Minimum of 2 years of experience developing in vitro assays for use in evaluating medical devices
• 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 educate and influence people from a broad range of disciplines
• Ability to travel up to 10%

Desired Qualifications

• Master’s degree or Ph.D. in Life Sciences, Biomedical Sciences, Biomedical Engineering or another relevant field
• Experience in the development and implementation of nonclinical models
• Experience in medical device or technology development and associated regulatory processes