Jobs at OrganOx

Lead and maintain ISO 14971-based risk management across product lifecycle for Class II/III medical devices. Develop and update risk files (FMEA, fault trees, benefit-risk), facilitate cross-functional risk reviews, ensure risk-driven V&V and verification of controls, monitor post-market data, support regulatory compliance and audits, and coach design teams on Design Assurance practices.

Investigate, analyze and trend product performance for a Class III medical device; lead root-cause analysis, SCAR/CAPA management, supplier quality interactions, returned-product testing, and implement manufacturing/inspection changes to mitigate failures while supporting sterilization, microbiology, and regulatory quality systems.

Define and lead QA and test strategy for regulated digital and data products. Own verification/validation, risk-based testing, automation, tooling and traceability. Collaborate with engineering, data science, regulatory and partners to ensure compliance with medical device standards and maintain test evidence for audits.

Field-based Territory Manager responsible for commercial sales, account management, and market development for OrganOx products within an assigned geography. Builds clinical and administrative relationships, executes launch and education programs, identifies new opportunities, supports customer onboarding and troubleshooting, and collaborates with cross-functional teams. Requires extensive travel and strong clinical aptitude in liver transplantation and medical device commercialization.

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.

The Senior Electronics Design Engineer will lead the design and development of electronic systems for medical devices, overseeing subsystems from concept to manufacturing, and mentoring junior engineers.

The Logistics Specialist manages customer orders, coordinates local and international shipments, and ensures compliance with logistics regulations. Responsibilities include documentation in SAP, problem-resolution for logistics issues, and process improvement initiatives.

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.

Design mechanical components and assemblies for medical devices using CAD, support engineering analysis, testing, prototypes and verification/validation. Collaborate with manufacturing, suppliers, and cross-functional teams. Prepare engineering documentation per ISO 13485, participate in risk management and design reviews, and support product development through testing and regulatory-compliant processes.

The VP, HR North America leads HR strategy aligned with business growth, manages global Talent Acquisition, oversees HR Operations, and promotes a performance-driven culture.

Support clinical investigations by managing site documentation, performing on-site and remote monitoring with oversight, assisting IRB submissions, training site staff, maintaining study files and databases, ensuring FDA/ICH/GCP compliance, and communicating with investigators and cross-functional teams.

Manage materials planning and inventory to ensure component and spare-part availability. Own SAP material master and item creation, develop Power BI KPIs, identify and implement AI/ML opportunities, support SAP users, participate in cross-functional projects, ensure ISO/FDA compliance, and coach planning teams to improve delivery and cost performance.