Clinical Research Engineer

Position Summary:

The Clinical Research Engineer is responsible for:

• Gaining an in-depth knowledge of the Company’s 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 employees (e.g. Clinical Specialists) and customers approved, as well as IDE and research products and studies.

Major Responsibilities:

Product Knowledge and Training:

• Gaining an in-depth knowledge of the Company’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 personnel on investigational/research devices and procedures
• Attend cases with investigational/research devices 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 devices to Development and Engineering

Clinical Studies:

• Serve as a resource to investigational/research centers, as well as 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 the Company 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 processes and procedures
• Other duties as assigned by VP, of Clinical Affairs & Training

Skills and 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

Qualifications:

• A certified Clinical Perfusionist degree is strongly preferred
• Other possible degrees: 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 a must
• Previous experience in the medical device industry with a 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