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OrganOx

OrganOx

www.organox.com

4 Jobs

186 Employees

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 background Company brand
Company Name
OrganOx
Job Title
Senior Full Stack Web Developer
Job Description
**Job Title** Senior Full Stack Web Developer **Role Summary** Lead end‑to‑end development of web and backend solutions, collaborating with internal teams and external partners. Deliver research tools and production systems, focusing on React front‑end and .NET/C# back‑end, while maintaining high quality, security, and compliance standards in a regulated medical device environment. **Expectations** - Design, code, test, and document full‑stack features that meet defined business and technical requirements. - Mentor junior developers, conduct code reviews, and promote best practices such as Clean Code, SOLID, TDD, CI/CD, and micro‑services. - Communicate effectively with Product Owners, Business Analysts, and cross‑functional stakeholders. - Ensure adherence to SOPs, regulatory compliance, and organisational code of conduct. **Key Responsibilities** - Develop and maintain front‑end components using React, TypeScript, HTML, CSS. - Build and expose scalable APIs with C#, .NET, and SQL/GIS databases. - Integrate cloud services (Azure, AWS, or GCP) and handle performance, security, and scalability. - Participate in Agile ceremonies (stand‑ups, retrospectives, sprint planning). - Write unit tests and support automated testing frameworks. - Create and maintain technical documentation and SOPs. - Collaborate with internal and external development partners, ensuring alignment on architecture and design. - Troubleshoot production issues, provide support, and manage configuration through DevOps pipelines. **Required Skills** - Full‑stack development with expertise in C#, .NET, SQL Server, Azure, React, TypeScript. - Experience with web & cloud technologies, RESTful APIs, CI/CD, Docker/Kubernetes. - Knowledge of security best practices, IoT/medical device contexts, and safety‑critical software principles. - Familiarity with Agile/Scrum, Test‑Driven Development, and micro‑service architecture. - Proficiency in a second language/platform (e.g., Java, Python, Android, iOS). - Strong problem‑solving, communication, documentation, and teamwork skills. **Required Education & Certifications** - Bachelor’s degree (or higher) in Computer Science, Software Engineering, or a STEM field (or equivalent professional experience). ---
Oxford, United kingdom
On site
Senior
18-11-2025
Company background Company brand
Company Name
OrganOx
Job Title
Product Quality Engineer - Disposable Set
Job Description
**Job title** Product Quality Engineer – Disposable Set **Role Summary** Provide technical quality engineering for the OrganOx Metra® disposable set, monitoring performance, root‑cause analyzing failures, and implementing corrective actions with suppliers and manufacturing teams to ensure compliance with medical device regulations. **Expectations** - Own the analysis of product performance data and recommend improvements. - Lead SCAR, NC, CAPA, and escalation handling, ensuring timely closure. - Collaborate cross‑functionally to implement process and inspection changes. - Maintain supplier relationships and support validation of supplier processes. - Deliver clear technical reports, change orders, and quality documentation. **Key Responsibilities** - Analyze and trend product performance data; provide improvement recommendations. - Initiate and follow up on SCARs, Nonconforming Material Reports, and CAPAs. - Conduct root‑cause investigations and resolve field failures, supporting engineering changes. - Work with suppliers and manufacturing to update inspection procedures and mitigate failures. - Validate new supplier processes and support process documentation (PFMEA, DHR, Service History). - Provide technical input on sterilization and microbiology processes. - Participate in engineering change reviews, complaints investigations, and CAPA actions. - Communicate findings and action plans to internal and external stakeholders. - Travel up to 10–20 % to supplier sites and events. **Required Skills** - Hands‑on medical device engineering experience with strong analytical skills. - Expertise in root‑cause analysis, Design of Experiments, test method development, and failure investigation. - Familiarity with FDA QSR, ISO 14971 risk management, and medical device sterilization/microbiology. - Proficient in MS Office, statistical analysis (Minitab), and Six Sigma principles. - Excellent technical and executive‑level written and verbal communication. - Strong cross‑functional collaboration, self‑directed problem solving, and global teamwork. **Required Education & Certifications** - Bachelor’s degree in Electrical, Mechanical, Biomedical, or related engineering discipline (or equivalent experience). - Knowledge of regulatory quality systems; ISO 14971 or FDA QSR understanding is essential.
Oxford, United kingdom
On site
18-11-2025
Company background Company brand
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 background Company brand
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