Clinical Research Engineer
OrganOx
Summary
The Clinical Research Engineer is responsible for gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures; serving as the subject matter expert on the device and procedures during IDE studies and research projects; and supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies.
Job description
Position Summary
The Clinical Research Engineer is responsible for gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures; serving as the subject matter expert on the device and procedures during IDE studies and research projects; and supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies.
Major Responsibilities
Under direction from the VP, Clinical Affairs and Training, the Clinical Research Engineer will be responsible for:
Product Knowledge and Training
- Gaining an in-depth knowledge of OrganOx 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 personnel, regarding investigational/research devices and clinical study protocols
- Support the development of clinical study protocols
- Support sound and thorough data collection 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 matrix 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
Requirements
- Certified Clinical Perfusionist degree strongly preferred
- Bachelor's degree in health profession, science, or engineering field with strong technical and clinical background
- Masters 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
- Be able to travel regularly within North America as required
- Right to work in the USA
- Have a full driver's license
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Disability coverage
- Flexible spending accounts
- 401(k) retirement plan
- Paid time off
- Holidays
- Employee discounts
- Onsite wellness facility
Company overview
OrganOx is a pioneering medical technology company specializing in advanced organ preservation devices for transplantation. Founded in 2008 as a spin-off from the University of Oxford by Professor Peter Friend and Professor Constantin Coussios, the company developed the world's first normothermic liver perfusion device, the metra® system. This innovative technology enables normothermic machine perfusion (NMP), which preserves organs at near-body temperature by circulating oxygen and nutrient-rich perfusate, allowing for real-time monitoring of organ condition during storage and transport. The metra® system has been used in over 6,000 liver transplant procedures globally and has received regulatory approvals in the U.S., Europe, Australia, and Canada. OrganOx's technology addresses critical challenges in organ transplantation by improving organ utilization rates, enabling the use of marginal donor organs, enhancing post-transplant outcomes, and reducing the burden on healthcare professionals. In 2025, the company was acquired by Terumo Corporation for approximately $1.5 billion, marking Terumo's strategic entry into the organ transplantation sector. OrganOx continues to expand its technology platform, with investigational applications for kidney transplantation and partnerships for innovative organ support solutions.