4 of 4 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 ...

including functional testing, usability, robustness, and stability studies for the different devices coming through R&D. Oversee verification and validation activities in accordance with ISO 13485 and FDA/EMA expectations. Interpret and report data from device testing and stability programs. Support regulatory submissions with technical documentation … client projects, providing expert guidance and problem-solving. Mentor junior device technologists and review technical work. Provide technical input into design controls, risk management (ISO 14971), and usability engineering (IEC 62366). Contribute to continuous improvement of laboratory methods and quality systems. Align with Regulatory on strategy for verification ...

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 ...