OrganOx

About the Company

"Living Organs For Life"
Transforming transplantation with the OrganOx metra®. A transportable, automated ex vivo liver perfusion device.

The core technology employed by the OrganOx metra® has been in development for over 15 years. During this time both of the founders (Professor Peter Friend and Professor Constantin Coussios) have driven the development of organ preservation and maintenance, formerly at the University of Cambridge and latterly at the University of Oxford.

OrganOx Limited was founded in April 2008 as a spin-out from the University of Oxford.

Conventional cold preservation involves storage of the liver at 4˚C, using a non-physiological perfusion solution that aims to minimise liver decay. By contrast, warm preservation seeks to re-create an environment that mimics the human body by continuously perfusing at physiological pressures and flows with oxygen-carrying red cells at 37˚C and providing nutrition. The liver is therefore functional during the preservation period, producing bile, metabolizing glucose and maintaining a physiological pH. This enables objective assessment of organ performance prior to transplant, extended preservation times, and the potential use of organs that are presently being discarded.

Listed Jobs

Company Name

OrganOx

Job Title

Logistics Specialist

Job Description

**Job title:** Logistics Specialist **Role Summary** Ensures accurate, compliant logistics flow for a regulated medical device organization. Manages shipment tracking, inventory coordination, customs compliance, and continuous cost optimisation using SAP and related tools. Collaborates cross‑functionally with production, R&D, and freight partners to meet delivery performance targets. **Expectations** - Maintain up‑to‑date shipment and inventory records in SAP. - Contribute to ISO 13485, BSI, and FDA compliant processes. - Drive continuous improvement and cost‑saving initiatives. **Key Responsibilities** - Track shipments and coordinate inventory across all warehouse sites. - Conduct cycle counts, investigate discrepancies, and support quarterly audits. - Monitor shelf‑life, calibration, and serialisation of inventory. - Develop dashboards and key performance metrics for shipment and inventory. - Align logistics availability with production, service, and R&D schedules. - Manage unallocated stock, shortages, and internal transfers. - Forecast demand, mitigate supply risks, and organise transportation schedules. - Support kitting operations and consumable replenishment. - Coordinate inbound/outbound shipments, ensuring timely, cost‑effective delivery. - Prepare and review customs documentation, tariff classifications, and import taxes. - Liaise with freight partners and regulatory teams, resolving customs queries. - Update processes in response to customs legislation changes. - Ensure processes meet ISO 13485, BSI, and FDA standards; maintain SOPs and risk assessments. - Record non‑conformance, conduct root‑cause analysis, and support CAPA actions. - Identify opportunities to reduce shipping costs via consolidation, carrier selection, and customs strategy. - Support cross‑functional projects to improve operational efficiency. **Required Skills** - Experience in materials, inventory, or logistics coordination. - Proficient in ERP systems (SAP preferred). - Knowledge of ISO 13485, FDA, BSI regulated environments. - Expertise in international shipping, customs documentation, and tariff application. - Advanced Excel and data analysis skills. - Strong problem‑solving, communication, and stakeholder engagement. **Required Education & Certifications** - Minimum A‑levels or equivalent in business, science, or engineering; or equivalent vocational qualifications (e.g., CILT Level 3 Certificate in Logistics & Transport, IoSCM Level 3‑5 in Inventory or Supply Chain Management). - Professional certifications highly valued: - CILT Level 3 Certificate in Logistics & Transport - IoSCM Inventory Management Certification - Lean Six Sigma Yellow or Green Belt - Health & Safety certification (e.g., IOSH Managing Safely) - SAP ERP training or certification

Oxford, United kingdom

On site

27-11-2025

Company Name

OrganOx

Job Title

Mechanical Design Engineer (FEA)

Job Description

**Job title:** Mechanical Design Engineer (FEA) **Role Summary:** Design and develop mechanical components and assemblies for medical devices, performing detailed finite element analysis (structural, thermal, fluid) to validate performance and safety prior to prototyping, and ensuring compliance with regulatory standards. **Expactations:** - Deliver FEA‑validated designs that meet performance, safety, and regulatory requirements. - Collaborate closely with electrical, quality, manufacturing, and regulatory teams. - Provide engineering documentation in line with ISO 13485 and related standards. - Contribute to risk management, design reviews, and continuous improvement of design processes. - Travel up to 10 % as required. **Key Responsibilities:** 1. Create mechanical component and assembly designs using CAD tools (SolidWorks). 2. Conduct and interpret structural, thermal, and fluid FEA using ANSYS or SolidWorks Simulation. 3. Verify manufacturability and cost‑effectiveness; coordinate with suppliers and manufacturing partners. 4. Support prototype production, perform design verification and validation activities. 5. Draft engineering documentation, design histories, and change control records. 6. Participate in risk assessments and design review meetings. 7. Maintain compliance with ISO 13485, ISO 14971, and other applicable standards. **Required Skills:** - Industrial mechanical design experience with a dedicated focus on FEA. - Proficiency in SolidWorks CAD and FEA tools (ANSYS or SolidWorks Simulation). - Strong knowledge of materials, manufacturing processes, and mechanical testing. - Experience in regulated environments, preferably medical devices. - Ability to interpret and apply ISO 13485, ISO 14971, and risk management principles. - Excellent analytical, problem‑solving, and communication skills. **Required Education & Certifications:** - Bachelor’s degree or higher in Mechanical Engineering or related field (or equivalent experience). - Demonstrated experience across the full product lifecycle from concept to production. - Valid certifications in FEA or advanced CAD are beneficial.

Oxford, United kingdom

On site

02-12-2025

Company Name

OrganOx

Job Title

Program Manager

Job Description

**Job Title** Program Manager **Role Summary** Oversee end‑to‑end delivery of assigned programs within a regulated medical device environment, ensuring scope, schedule, cost, quality, and risk targets are met. Collaborate with cross‑functional stakeholders, maintain governance frameworks, and report performance to senior leadership. **Expectations** - Lead multiple program or project teams without direct authority. - Ensure strict compliance with ISO 13485, IEC 60601, ISO 14971, and applicable regulatory frameworks (MDR). - Deliver financial stewardship across concurrent project budgets. - Drive continuous improvement through lessons learned and process optimization. **Key Responsibilities** 1. Plan, direct, and coordinate program activities in partnership with Functional Directors. 2. Develop and maintain work packages: charters, budgets, risk assessments, plans, and communication documents. 3. Generate and present program scorecards and KPI dashboards to senior leaders. 4. Manage stakeholder relationships, ensuring clear communication and expectation alignment. 5. Apply governance standards and best practices across program lifecycle. 6. Review resource plans, identify constraints, and collaborate on mitigation actions. 7. Conduct post‑project reviews, capture lessons learned, and implement improvements. 8. Monitor financial forecasts, budget adherence, and report deviations. 9. Ensure adherence to the organization’s Code of Conduct and policies. **Required Skills** - Proven program/project management experience in medical device or pharmaceutical industry. - Deep understanding of ISO 13485, IEC 60601, ISO 14971 risk management, and IEC 62304 digital/SAMD development. - Strong financial management with multi‑budget oversight. - Excellent stakeholder engagement, negotiation, and communication across all seniority levels. - Leadership of cross‑functional teams without direct authority. - Proficiency in standard office, project management, and engineering software. - Ability to manage distributed teams via collaboration platforms. - Demonstrated problem‑solving, initiative, and a pragmatic, solution‑focused mindset. **Required Education & Certifications** - Bachelor’s degree in Engineering, Life Sciences, Business, or related field. - Project Management Professional (PMP) or equivalent certification preferred. - Additional certifications in medical device risk management or regulatory compliance are advantageous.

Oxford, United kingdom

On site

26-12-2025