Senior Design Assurance Engineer - Medical Device Risk

OrganOx; Oxford; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Healthcare plans

Retirement plans

Professional development

Job summary

OrganOx is seeking a Senior Design Assurance Engineer to drive risk management for Class II/III medical devices. You will work closely with R&D, Engineering, Post-Market Operations and Quality teams at our Oxford facility to ensure robust risk assessment, verification, and regulatory compliance.

The role focuses on lifecycle risk management, risk documentation, and collaboration across multidisciplinary teams to maintain high safety and quality standards.

Qualifications

• Excellent written and verbal communication skills.
• Proven ability to work in a multi-disciplinary environment.
• Strong analytical and problem-solving abilities.
• Experience in risk management for medical devices or regulated industries.
• Familiarity with ISO 14971 and risk-based design approaches.
• Knowledge of domestic and international regulatory requirements.
• Experience with quality management systems and SOPs.
• Ability to coach and mentor colleagues.
• Ability to meet strict timescales and adapt to changing priorities.
• Experience participating in design reviews and full product lifecycle.

Responsibilities

• Lead risk management activities across the full product lifecycle per ISO 14971 and OrganOx procedures for Class II & III medical devices.
• Develop, update, and maintain risk management files, including hazard analyses, FMEAs, fault trees, benefit-risk assessments, and risk traceability.
• Facilitate and document risk reviews for new and existing devices with cross-functional input.
• Support verification and validation activities by ensuring risk-driven test coverage and review of protocols/reports.
• Monitor post-market data to ensure risks remain acceptable and design files stay current.
• Ensure compliance with global regulatory requirements and support audits.
• Collaborate with design teams to uphold Design Assurance throughout development.
• Contribute to other Design Assurance tasks to support the Quality function.
• Adhere to OrganOx Code of Conduct and company policies.

Skills

Communication skills

Multidisciplinary teamwork

Analytical/problem-solving

Risk management

ISO 14971

Regulatory knowledge

Coaching/mentoring

Education

Degree in bioscience/engineering

Willingness to travel

Job description

OrganOx is seeking a Senior Design Assurance Engineer to drive risk management for Class II/III medical devices. You will work closely with R&D, Engineering, Post-Market Operations and Quality teams at our Oxford facility to ensure robust risk assessment, verification, and regulatory compliance.

The role focuses on lifecycle risk management, risk documentation, and collaboration across multidisciplinary teams to maintain high safety and quality standards.