[Hiring] Clinical Research Engineer @OrganOx

Role Description

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.
• Supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies.

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.
• Supporting the development of training and other support materials for FDA approved and investigational/research devices and procedures.
• Training investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures.
• Attending cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center.
• Interfacing with Development and Engineering in order to obtain answers to technical questions.
• Providing clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering.

Clinical Studies

• Serving as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols.
• Supporting the development of clinical study protocols.
• Supporting sound and thorough data collection to ensure data analysis in accordance with the protocol.
• Developing training and other support materials for clinical protocols, study procedures, data collection and review.
• Assisting in the development and implementation of a study-specific database for clinical studies.
• Assisting Clinical Research Associates with review of study data.
• Supporting writing and review of clinical study reports and the clinical portion of FDA submissions.
• Identifying and reporting study protocol challenges and compliance issues to clinical management.

Management Support

• Supporting OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites.
• Serving 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.

Qualifications

• Certified Clinical Perfusionist degree strongly preferred.
• Other possible degrees: Bachelor’s degree in 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.
• Be able to travel regularly within North America as required.
• Right to work in the USA.
• Have a full driver’s license.

Benefits

• Competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts.
• 401(k)-retirement plan with company matching after 90 days.
• Paid time off, holidays, and additional leave benefits.
• Employee discounts and access to our onsite wellness facility.
• Support for work-life balance and opportunities for ongoing professional development.