Clinical Research Engineer

New
O
OrganOxMedical Devices
Cleveland, Ohio, United States. Philadelphia, Pennsylvania, United States. Nashville, Tennessee, United States. Atlanta, Georgia, United StatesFull-TimeMiddle
Salary not disclosed
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Job Details

Required Skills
Project ManagementData AnalysisMicrosoft Office

Requirements

  • Certified Clinical Perfusionist degree strongly preferred.
  • Bachelor’s degree in a health, science, or engineering field; Master’s degree preferred.
  • Direct experience with perfusion devices and management of patients or donor organs.
  • Previous experience in the medical device industry, specifically transplant or perfusion technology.
  • Knowledge of project management tools and practices.
  • Computer literacy, including proficiency in Microsoft Word, Excel, and PowerPoint.
  • Ability to work effectively in a matrix organization.
  • Strong communication and presentation skills.
  • Analytical approach to problem-solving and excellent organizational skills.
  • Must possess a full driver's license.
  • Ability to travel regularly within North America.

Responsibilities

  • Gain in-depth knowledge of FDA approved and investigational OrganOx products and clinical procedures.
  • Support the development of training materials for approved and research-stage devices.
  • Train research centers and internal personnel on study protocols and device operation.
  • Attend clinical cases to provide technical and clinical resource support.
  • Collaborate with development and engineering teams to provide technical feedback and address design queries.
  • Assist in the design and implementation of study-specific databases and support data collection/review.
  • Contribute to the writing and review of clinical study reports and FDA regulatory submissions.
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