Software Quality Engineer – MedTech (SFMEA, Cybersecurity)

OrganOx Limited; Oxford; Presencial; GBP 55.000 - 75.000; Jornada completa

Descripción de la vacante

OrganOx Limited is seeking a Software Quality Engineer to join its fast-growing Quality team in Oxford. You will work with R&D, Engineering, Post-Market Operations and Regulatory Affairs to ensure software compliance across the lifecycle of OrganOx products, including SFMEA creation, risk analyses and cybersecurity oversight.

The role emphasizes regulatory alignment (EU MDR, FDA) and robust software risk management, with opportunities to influence design reviews and release readiness in a

Formación

• Experience as a software quality engineer in the medical device industry (SaMD, digital health apps or software in a medical device).
• Experience developing, facilitating and reviewing SFMEAs and software hazard analyses for medical-device software under ISO 14971.
• Experience reviewing software requirements, architecture, traceability, verification evidence, changes and release documentation.
• Knowledge of IEC 62304, ISO 14971, ISO 13485, EU MDR and applicable FDA software requirements and guidance.

Responsabilidades

• Ensure software quality across the full lifecycle per IEC 62304 and OrganOx standards.
• Oversee software design controls, requirements, verification, validation and release management.
• Maintain traceability between hazards, requirements and verification evidence.
• Lead cybersecurity risk management activities including threat modelling and vulnerability assessment.
• Support CSV/CSA and validation activities; ensure regulatory compliance.
• Contribute to design reviews, risk reviews, and release readiness.
• Adhere to OrganOx Code of Conduct and company policies.

Conocimientos

Software quality engineering

SFMEA

Hazard analysis

Cybersecurity risk assessment

CSV

Regulatory standards

ISO 14971

IEC 62304

ISO 13485

GAMP5

Risk management

Educación

Degree in software engineering or related field

Descripción del empleo

OrganOx Limited is seeking a Software Quality Engineer to join its fast-growing Quality team in Oxford. You will work with R&D, Engineering, Post-Market Operations and Regulatory Affairs to ensure software compliance across the lifecycle of OrganOx products, including SFMEA creation, risk analyses and cybersecurity oversight.

The role emphasizes regulatory alignment (EU MDR, FDA) and robust software risk management, with opportunities to influence design reviews and release readiness in a