8 of 8 ISO 13485 Jobs in the Thames Valley

full software development lifecycle, including requirements definition, architecture, implementation, testing, risk, cybersecurity and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, ISO 14971 and other relevant safety standards. Establish and enforce high-quality software design control practices, including code reviews. … 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 ...

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 ...

. Qualifications: Degree in Mechanical, Electrical, Mechatronics, or Automation Engineering (or equivalent hands-on experience). Pluses: Robotics integration (6-axis/SCARA), ISO 13485/GAMP knowledge, or Six Sigma training. ...

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. We do not require previous experience specifically in hardware or embedded-software testing, web front-end testing, clinical ...

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 ...

other cancers a plus) International experience (work or study abroad) esp in North America, Europe and APAC Experience working within regulated environments (e.g. ISO 13485) What we offer Work that is both challenging and rewarding and has a real positive impact on people's lives Fast growth, ownership ...