Software Quality Engineer: Medical Devices (Oxford, Onsite)

OrganOx, Inc.; Oxford; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Healthcare

Retirement plans

Job summary

OrganOx in Oxford, UK, is seeking a Software Quality Engineer to drive quality across the software lifecycle for medical device applications, including SaMD and cybersecurity considerations. You will partner with R&D, Engineering, and Regulatory Affairs to ensure robust risk management and regulatory compliance.

The role focuses on SFMEAs, software hazard analyses, traceability, and documentation aligned with ISO 13485, IEC 62304, EU MDR, and FDA requirements.

Qualifications

• Experience as a software quality engineer in the medical device industry, supporting SaMD or software in a medical device.
• Experience developing SFMEAs and software hazard analyses under ISO 14971.
• Experience reviewing software requirements, architecture, traceability, verification evidence, changes and release documentation.
• Experience with cybersecurity risk assessment and CSV-related activities (Desirable).

Responsibilities

• Assure software quality across the full lifecycle per OrganOx standards for software up to safety class C per IEC 62304.
• Provide oversight of software design controls, including requirements, architecture, verification and release management.
• Maintain traceability between hazards, requirements, risk controls and verification evidence.
• Ensure alignment of SFMEAs with system-level risk analyses and ISO 14971.
• Oversee regulatory documentation to meet EU MDR and FDA software requirements.

Skills

Software quality

Medical device software

Risk management

Cybersecurity risk assessment

Regulatory compliance

Cross-functional collaboration

Analytical communication

Education

Degree in software engineering or related discipline

Job description

OrganOx in Oxford, UK, is seeking a Software Quality Engineer to drive quality across the software lifecycle for medical device applications, including SaMD and cybersecurity considerations. You will partner with R&D, Engineering, and Regulatory Affairs to ensure robust risk management and regulatory compliance.

The role focuses on SFMEAs, software hazard analyses, traceability, and documentation aligned with ISO 13485, IEC 62304, EU MDR, and FDA requirements.