Study Director
W. L. Gore & Associates - Flagstaff, AZ

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101808

Description

W.L. Gore & Associates is seeking a research biologist to join a team of bioscience and product development professionals in the Medical Products Division responsible for in vivo preclinical evaluation of biomaterials and medical devices. This individual will help drive developing, organizing, and designing pre-clinical studies for existing and new medical devices as well as new biomaterials that may be developed. Primary responsibilities will include functioning as the key liaison between the product development teams and the appropriate testing facilities by driving overall coordination of the pre-clinical testing studies. These studies will include fundamental research, new product development, and commercial product evaluations. This associate will be expected to develop a thorough understanding of clinical product applications and translate those needs into preclinical safety and performance testing strategies to demonstrate biological safety to support domestic and international regulatory submissions of medical devices. This position will involve partnership and interaction with a broad group of associates including product specialists, product development teams, engineers, scientists, regulatory and business associates. This individual will assist in leveraging of existing animal models, developing new model development, and external collaborations with outside investigators as needed. Close collaboration and partnership with our internal preclinical bioscience team will be important. Travel will be required of approximately 10% of time.

Qualifications

Requirements: The ideal candidate will have:
  • A PhD in anatomy, cell biology, physiology or related bioscience field with 5-10 years relevant experience.
  • Understanding of animal and clinical anatomy and physiology.
  • Appreciation and/or experience in surgical and interventional procedures.
  • Working knowledge of histopathology and evaluations.
  • Knowledge of biomaterials and medical device performance testing.
  • Experience and ability to function as study director for protocols.
  • Ability to analyze data and write final reports.
  • Demonstrated ability to work effectively under GLP compliance requirements.
  • Strong scientific rigor with ability to critically review the literature and to provide scientific review of protocols.
  • Excellent written and verbal communication skills to educate and influence people from a broad range of disciplines in the medical device field.
  • Self-motivation and the ability to work independently, as well as work effectively within a team environment.
  • Willingness and ability to work across multiple locations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.

EEO/AA Employer (applies to all positions located in the U.S.)

Job

:

Engineer/Scientist

Primary Location

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North America-United States-Arizona-Flagstaff

Travel

:

Yes, 10% of the time

Shift

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Day (1st shift)

About this company
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W. L. Gore & Associates (Gore) is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Our...