5 of 5 ISO 13485 Jobs in the South East

Conduct code reviews, debugging, and optimisation with a focus on performance and power efficiency. Apply regulatory standards and software development lifecycle processes (IEC 62304, ISO 13485) throughout the project. Collaborate with hardware engineers to interpret schematics and datasheets. Produce and maintain technical documentation, including software requirements, design specifications … microcontrollers and associated toolchains (GCC, CMake, etc.). Proficient with RTOS environments such as FreeRTOS or Zephyr. Experience working within regulated industry (IEC 62304, ISO 13485). Proficient with version control (Git) and hardware debugging tools (oscilloscopes, logic analysers). Comfortable working autonomously. Nice-to-Have: Experience with ...

teams to support defect triage, issue resolution, and validation. Monitor regulatory changes and ensure compliance with standards such as IEC 60601 and ISO 14971. Conduct risk management activities including FMEA and hazard analysis. Champion continuous improvement across engineering tools and processes. Required Experience & Qualifications Essential: Bachelors degree in biomedical … mechanical, electrical, or systems engineering (or equivalent). Strong background in high-reliability systems (e.g., ventilators). Deep understanding of ISO 14971 and IEC 60601-1 standards. Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release. Familiarity with ISO/IEC/IEEE ...

Linux system administration and networking concepts would be useful Any experience of working within a regulated setting and working to one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person ...

development Collaborate with external vendors/suppliers Support documentation required for testing You will bring the following Hands on software engineering within a ISO13485 environment Experience in full stack development across Azure Previous background in web and and cloud technologies BSc or MSc in a relevant Life Sciences subject ...

architect strategies Line management of a small team You will bring the following Hands on software engineering within medical devices with standard experience win ISO13485 and IEC62304 Prior experience as an Architect Full stack experience with IoT, cloud, web for both frontend and backend Previous track record of working across ...