Jobs at OrganOx

Supports product engineering for medical organ-perfusion devices, including design changes, verification, troubleshooting, root-cause analysis, testing, prototyping, and continuous improvement. Collaborates with product development, operations, quality, customer service, suppliers, and manufacturers. Creates technical documentation, design history files, device master records, assembly instructions, test strategies, and regulatory-quality reports in compliance with ISO 13485 and applicable procedures.

Manages warehouse, logistics, inventory, and distribution operations across the UK and EU. Oversees third-party logistics partners, inventory accuracy, supply chain risk, KPIs, continuous improvement, business continuity planning, and distribution network optimization. Leads direct reports, coordinates cross-functional activities, supports S&OP and IBP processes, and ensures operational compliance and performance. The role is based onsite in Oxford and requires travel of up to 10%.

The Operations Manager coordinates U.S. distribution, warehousing, inventory, logistics, and supply chain activities. Responsibilities include managing logistics partners, maintaining inventory accuracy and safety stock, monitoring KPIs, improving operational performance, mapping distribution networks, mitigating supply chain risks, and supporting business continuity. The role also involves team development, cross-functional collaboration, supplier management, reporting, and continuous improvement. This is an on-site position with up to 10% domestic and international travel.

Designs and develops mechanical components and assemblies for medical devices. Responsibilities include CAD design, engineering analysis, testing, prototyping, design verification and validation support, manufacturing collaboration, technical documentation, risk management, and cross-functional work with electrical, software, quality, regulatory, and manufacturing teams.

Leads a Windows software engineering team developing and maintaining safety-critical applications for Class II and III medical devices. Owns architecture, SDLC execution, technical decisions, regulatory compliance, quality, releases, budgets, hiring, and team development. Oversees connectivity, cybersecurity, edge-to-cloud integration, OTA updates, and continuous improvement while collaborating with cross-functional teams, external partners, regulators, and customers.

Leads software testing for Class II and III medical devices, including strategy, protocols, automation, integration testing, risk analysis, verification reporting, release quality, and CI/CD implementation. Manages and develops software test engineers, resources, budgets, vendors, and cross-functional stakeholders. Ensures compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and related standards while overseeing software configuration, cybersecurity, post-market surveillance, design controls, and continuous improvement.

Designs and develops electronics systems for medical devices across the full lifecycle, including circuit design, schematic capture, PCB layout, prototyping, testing, verification, documentation, troubleshooting, and manufacturing transfer. The role collaborates with mechanical, software, systems, quality, and regulatory teams while ensuring compliance with medical device standards, safety requirements, EMC considerations, and design-for-manufacture principles.

Lead data quality and reporting for complaints and servicing systems: cleanse and validate data, build reports and dashboards, perform advanced statistical analyses, automate data extraction, maintain databases, and collaborate with stakeholders to surface actionable insights and process improvements.