Jobs at OrganOx

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.

Manages and delivers clinical and technical training programs for customers, internal staff, partners, and field teams. Develops curricula, educational materials, demonstrations, workshops, and ongoing training initiatives related to the OrganOx metra device and normothermic machine perfusion. Oversees the training center, mentors clinical and sales personnel, supports customer adoption, gathers feedback, and collaborates cross-functionally to advance clinical education and commercial objectives.

Process and verify supplier invoices, manage the full accounts payable cycle, maintain vendor records, resolve discrepancies, reconcile statements, manage payments, review accounts receivable, and support month-end close. The role also involves bank transaction posting, cross-functional issue resolution, and participation in accounting system implementation and process improvements. This is an onsite six-month fixed-term contract in Oxford.

Ensures cloud platforms and embedded medical-device software meet quality, regulatory, cybersecurity, and risk-management requirements. Responsibilities include maintaining software technical files, developing compliant processes and documentation, overseeing testing and tool validation, managing CAPAs and SOUP, conducting FMEA and threat modeling, coordinating penetration testing, and partnering with software, quality, regulatory, and product teams. The role requires medical-device software quality assurance expertise, knowledge of relevant standards, and experience with cloud platforms and CI/CD practices.

Supports clinical studies and investigational medical device programs for organ perfusion technology. Responsibilities include device and procedure training, clinical site support, protocol and study material development, data collection and review, database implementation, clinical study reports, FDA submission support, compliance monitoring, and technical feedback to engineering and development teams. Regular travel to research sites and case support are required.

Provides training and onsite or remote support to organ retrieval and transplant teams using the OrganOx metra system. Organizes site initiation, refresher, and centralized training; supports clinical and research activities; collects product performance data; develops case studies; and maintains quality and vendor credentialing requirements. The role requires extensive travel, 24/7 on-call availability for approximately 15 days monthly, conference participation, and collaboration with transplant teams and internal stakeholders.

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.

Supports global medical device regulatory submissions, registrations, renewals, and product lifecycle activities across the U.S., EU, Canada, Australia, and other markets. Maintains regulatory records, coordinates deliverables across product areas, supports regulatory authority and Notified Body interactions, and helps configure and improve the Rimsys regulatory information management system. The role also aligns regulatory data with change control, product configurations, approvals, and recurring compliance obligations.

Develop and maintain secure, scalable backend services, APIs, databases, integrations, and Azure cloud solutions for regulated and non-regulated digital products. Responsibilities include automated testing, DevOps and CI/CD, infrastructure automation, technical documentation, troubleshooting, production monitoring, architecture reviews, and compliance with quality, cybersecurity, regulatory, and data-protection requirements. The role collaborates with Product Owners, Business Analysts, internal teams, and external partners in an onsite Oxford environment.

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.

Lead complaint and servicing data analytics: ensure data integrity, cleanse and aggregate data from databases/APIs, build automated reports and dashboards, apply statistical analysis to surface insights, design extraction scripts, and collaborate with stakeholders to drive process improvements and support decision-making.