Clinical Research Engineer

OrganOx

. Gain in-depth knowledge of OrganOx FDA-approved and investigational/research products and associated clinical procedures .

Posted 9/19/2026full-timeRemote • Ohio • United StatesMid-LevelSenior💰 $170,000 - $190,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical procedures and investigational devices, with a strong focus on training, protocol development, and compliance in clinical studies. Proficient in project management and data analysis, with a solid background in the medical device industry, particularly in perfusion and transplant technologies.

Highest-signal resume keywords

Clinical Study Protocol DevelopmentPerfusion Device ManagementTraining and Support Material DevelopmentClinical Data AnalysisCertified Clinical Perfusionist

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ProceduresData CollectionClinical Study ReportsProject Management ToolsAnalytic Problem Solving

Soft Skills

Strong Communication SkillsExcellent Organizational SkillsAbility to Work IndependentlyTeam Collaboration

Tools & Technologies

WordExcelPowerPoint

Certifications & Qualifications

Certified Clinical PerfusionistBachelor’s Degree in Health Profession or ScienceMaster’s Degree Preferred

Industry Keywords

Medical Device IndustryTransplant DevicesClinical StudiesInvestigational DevicesFDA Submissions

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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