Teams 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.