Clinical Research Engineer — Med Device Trials & Training

OrganOx Limited; Philadelphia (Philadelphia County); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Vision plan

Disability coverage

401(k) match

Paid time off

Holidays

Wellness facility

Job summary

OrganOx is seeking a Clinical Research Engineer to become the subject matter expert on FDA-approved and investigational OrganOx devices and procedures, supporting IDE studies and training staff and customers. The role involves training, developing materials, and collaborating with staff to ensure compliance and high-quality data collection.

You will support clinical study protocols, assist with data collection and review, and provide input to FDA submissions.

Qualifications

• Demonstrated knowledge of relevant therapeutic areas and ability to learn new areas.
• Experience in a clinical setting and in clinical studies is beneficial.
• Strong project management tools and practices; matrix organization experience.

Responsibilities

• Serve as SME on FDA approved and IDE/research devices and procedures.
• Support training of OrganOx staff and customers on devices and studies.
• Assist in development of training materials and data collection processes.
• Support writing and review of clinical study reports and FDA submissions.
• Collaborate with Development and Engineering to answer technical questions.

Skills

Clinical research

Training delivery

Data collection

Project management

Communication

Analytical thinking

Teamwork

Presentation skills

Education

Certified Clinical Perfusionist degree

Bachelor’s degree in health profession, science, or engineering

Masters degree preferred

Tools

Word

Excel

PowerPoint

Job description

OrganOx is seeking a Clinical Research Engineer to become the subject matter expert on FDA-approved and investigational OrganOx devices and procedures, supporting IDE studies and training staff and customers. The role involves training, developing materials, and collaborating with staff to ensure compliance and high-quality data collection.

You will support clinical study protocols, assist with data collection and review, and provide input to FDA submissions.