OrganOx

Clinical Research

• 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
• - 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 Enginer 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

Clinical Research Engineer

Procurement

• Act as the primary point of contact for all CDMO-related activities and issues within the United States.
• Develop and maintain effective relationships with local US suppliers to foster collaboration and trust.
• Be responsible for strategy input and execution for suppliers supporting the American market only.
• Deliver key category performance indicators, including savings, risk mitigation, and quality assurance within the US supply base.
• Supplier selection, onboarding, lifecycle management, and potential management of phase-out specific to the US market, rationalise supplier base,
• Reorganize supply chain.
• Redefine supplier strategy
• Collaborates with suppliers, regulatory and quality team to implement and monitor quality assurance protocols specific to medical devices, ensuring adherence to industry best practices and regulatory requirements.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies
• End to end supply chain management of key suppliers including business reviews to manage KPI's

Outsourcing Operations Leader

QA Engineer

• ABOUT ORGANOX:
• OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Product Quality Engineer to join our team.
• Position Summary
• The Product Quality Team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance, in addition to owning quality processes within the service organization.
• The Product Quality Engineer will be technical, hands-on, and customer focused with an ability to analyze, diagnose and test product quality issues. The successful candidate is accountable, collaborative, has excellent communication and problem solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer.