7 of 7 ISO 13485 Jobs in Oxfordshire

risk‐control measures and verification evidence. EnsuresoftwareFMEAs are aligned with system‐level risk analyses, including system FMEAs, use‐related risk analyses and the overall ISO 14971 risk‐management file. Review software lifecycle documentation for completeness, consistency, traceability and regulatory compliance. Participate in design reviews, risk reviews, change assessments, project … cybersecurity risk management, including threat modelling, vulnerability assessment, SOUP and third‐party software. Maintain and improve software procedures in line with IEC 62304, ISO 13485, ISO 14971, EU MDR, applicable FDA requirements and cybersecurity guidance. Supporting Quality oversight of computer system validation/assurance (CSV)/CSA. ...

Oversee the full software development lifecycle, including requirements definition, architecture, implementation, testing, and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, and other relevant safety standards. Establish and enforce high-quality software engineering practices, including code reviews, architectural governance, and design … accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

considerations and design-for-manufacture principles. Experience with electronic testing tools such as oscilloscopes, spectrum analysers, and logic analysers. Understanding of medical device standards (ISO 13485, IEC 60601, IEC 62304) is an advantage. Ability to troubleshoot and solve complex design issues. Effective communication skills for working within cross ...

electromechanical machinery. Technical Basics: Familiarity with 3D CAD, electrical schematics, and industrial sensors/actuators. Bonus Points: Exposure to medical device/biotech standards (ISO 13485), basic robotics, or precision fluid handling. ...

framework. Training and mentoring junior members of the team. Promote automation-first thinking within the testing team. Compliance with the MDD/MDR and ISO 13485/62304 standards for validation and verification of software medical devices. Skills & Experience Required: Essential Strong Python programming skills, including object-oriented ...

statistical acceptance criteria and data-driven testing. Biomedical, healthcare or digital-health experience. Experience in regulated medical technology environments. Familiarity with IEC 62304, ISO 13485 or related medical-device standards. Standard Employee Benefits Employee share option scheme 22 days' annual leave plus UK bank holidays Company pension scheme ...

speed, and extend coverage across tests for medical device software validations. You will mentor juniors and promote automation-first practices while aligning with ISO 13485/62304 compliance requirements. #J-18808-Ljbffr ...