Clinical Research Engineer at OrganOx

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Clinical Research Engineer at OrganOx. OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx . metra. ® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.. Position Summary . The . Clinical Research Engineer. is responsible for: . - Gaining an in-depth knowledge of OrganOx’s products, as well as associated clinical procedures . - Serving as the subject matter expert on the device and procedures during IDE studies and research projects . - Supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx’s approved, as well as IDE and research products and studies.  . Major Responsibilities . Responsibilities may include the following and other duties may be assigned: .  . Product Knowledge and Training. . • Gaining an in-depth knowledge of OrganOx’s FDA approved and investigational/research products, as well as associated clinical procedures . • Support the development of training and other support materials for FDA approved and investigational/research devices and procedures . • Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures . • Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center . • Interface with Development and Engineering in order to obtain answers to technical questions . • Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering . Clinical Studies . • Serve as a resource to investigational/research centers, as well as OrganOx’s personnel, regarding investigational/research devices and clinical study protocols . • Support the development of clinical study protocols . • Support sound and thorough data collection to ensure data analysis in accordance with the protocol . • Develop training and other support materials for clinical protocols, study procedures, data collection and review . • Assist in the development and implementation of a study-specific database for clinical studies . • Assist Clinical Research Associates with review of study data . • Support writing and review of clinical study reports and the clinical portion of FDA submissions . • Identify and report study protocol challenges and compliance issues to clinical management.  . Management Support . • Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites . • Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures . • Other duties as assigned by VP, Clinical Affairs & Training .  . Skills & Experience. •        Demonstrate aptitude in and knowledge of relevant therapeutic areas and ability to learn and integrate new/different therapeutic areas . •        Experience in a clinical setting and clinical studies is beneficial . •        Knowledge of project management tools and practices . •        Proven ability to work in a matrixed organization . •        Ability to work independently and as a part of a team . •        Have an analytic approach to problem solving . •        Excellent presentation and computer skills . •        Strong communicator, capable of effectively presenting ideas and concepts . •        Excellent organizational skills and attention to detail. ·       Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.  . The . Clinical Research Engineer. should/will have: . • Minimum 3 years of experience as a Certified Clinical Perfusionist (CCP) . • Bachelor’s degree in Cardiovascular Perfusion or other health profession, science, or engineering field with a strong technical and clinical background; Master’s degree preferred . • Experience with perfusion devices and management of patients or donor organs is a must . • Previous experience in the medical device industry with preference for transplant and perfusion devices is desired . • Computer literate and familiar with Word, Excel, and PowerPoint . • Must able to travel up to 50% of the time within North America as required and reside within one hour of a major airport hub to facilitate travel..  . A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. . #LI-Remote. Company Location: United States.