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W. L. Gore & Associates · 1 day ago

Scientist

Flagstaff, AZ

Full-time

Onsite

Entry, Mid Level

2+ years exp

W. L. Gore & Associates is seeking a Scientist to join their team, focusing on nonclinical testing methods for medical devices. The role involves collaboration with project teams, development of nonclinical models, and ensuring compliance with regulatory standards.

Health CareManufacturingMedical Device

No H1B

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

Qualification

Nonclinical testingVitro assaysScientific writingBiomedical EngineeringRegulatory processesCritical analysisProject managementMentoringCollaboration

Required

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%