Clinical Research Engineer

🔥 3 minutes ago

🏈 Ohio, Pennsylvania, +1 more states – Remote

🏈 Ohio – Remote 🔔 Pennsylvania – Remote 🎸 Tennessee – Remote

💵 $170k - $190k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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OrganOx

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

OrganOx is a company dedicated to transforming organ preservation to improve outcomes in liver transplantation. Their flagship product, the OrganOx metra, is a fully automated device for the normothermic preservation of donor livers. This device enables the functional assessment of donor organs prior to transplantation, reduces early allograft dysfunction, and enhances transplantation logistics. The OrganOx metra keeps the donor liver perfused with oxygenated blood, medications, and nutrients at normal body temperature, preserving it in a functional state for up to 24 hours. By supporting transplant teams, OrganOx aims to increase the number of donor organs available for transplant and improve the health outcomes for transplant recipients.

📋 Description

• Gain in-depth knowledge of OrganOx FDA-approved and investigational/research products and associated clinical procedures • Serve as the subject matter expert on devices and procedures during IDE studies and research projects • Support training of OrganOx employees and customers on approved, IDE, and research products and studies • Support development of training and support materials for devices, procedures, and clinical protocols • Train investigational/research centers, Clinical Specialists, and OrganOx personnel • Attend cases with investigational/research devices as a technical and clinical resource • Interface with Development and Engineering on technical questions • Provide clinical and technical feedback to Development and Engineering • Support investigational/research centers and OrganOx personnel regarding devices and clinical study protocols • Support development of clinical study protocols • Support thorough data collection and protocol-compliant data analysis • Develop materials for clinical protocols, study procedures, data collection, and review • Assist with development and implementation of study-specific clinical databases • Assist Clinical Research Associates with study data review • Support writing and review of clinical study reports and clinical portions of FDA submissions • Identify and report protocol challenges and compliance issues to clinical management • Maintain and develop professional relationships with investigators and research sites • Support clinical management with departmental quality improvement decisions • Perform other duties assigned by the VP, Clinical Affairs & Training

🎯 Requirements

• 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 matrix organization • Ability to work independently and as a part of a team • Analytic approach to problem solving • Excellent presentation and computer skills • Strong communication skills, capable of effectively presenting ideas and concepts • Excellent organizational skills and attention to detail • Certified Clinical Perfusionist degree strongly preferred • Bachelor’s degree in another 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 required • Previous experience in the medical device industry, preferably with transplant and perfusion devices, is desired • Computer literacy and familiarity with Word, Excel, and PowerPoint • Ability to travel regularly within North America as required • Right to work in the USA • Full driver’s license

🏖️ Benefits

• Health insurance • Dental insurance • Vision insurance • Disability coverage • Flexible spending accounts • 401(k)-retirement plan with company matching after 90 days • Paid time off • Holidays • Additional leave benefits • Employee discounts • Access to onsite wellness facility • Work-life balance support • Ongoing professional development opportunities