1 to 25 of 34 IEC 62304 Jobs in the UK

software across embedded, application, and UI layers. Own our full software stack - from real-time firmware to intuitive user interfaces. Introduce lean, agile development practices within a regulated framework (IEC 62304, ISO 13485). Build for extensibility - enabling third-party instrument development and open platform integrations. Collaborate cross-functionally with hardware, UX, clinical, regulatory, and quality teams. Manage … automotive). Proven track record delivering full-stack systems, including RTOS-based firmware and application software. Deep knowledge of modular, scalable platform architecture. Strong grasp of compliance standards like IEC 62304 and ISO 13485. Excellent communication, problem-solving, and team-building skills. Experience leading teams and delivering in dynamic, mission-driven environments. Your Background: Degree-qualified in software … engineering, computer science, electrical engineering, or related discipline. Bonus points for direct experience with IEC 62304 or ISO 13485. Willingness to travel occasionally for labs or customer collaboration. Why Join Us? This is a rare opportunity to own the software backbone of a system with global clinical impact. At Creo, you'll help define the digital infrastructure powering More ❯

system architecture and solving complex technical issues. Manage a growing team by conducting effective 1:1s, coach engineers, lead hiring and onboarding, and manage a career development framework. Own IEC 62304 traceability, architecture documentation, and release quality for critical features and audits. Establish agile delivery practices that work within the constraints of ISO 13485 and MDR/FDA … in a fast-paced, regulated medical or AI-based software environment, having delivered multiple health tech products Building and delivering clinical software products with end-to-end traceability under IEC 62304 and ISO 13485 Driving complex technical decision-making (e.g., architecture reviews, release criteria) Leading or supporting regulatory audits and inspections Managing stakeholders across Engineering, Product, QA, and … delivery, while adapting to evolving needs What success looks like: 3 months: Define team rituals that promote alignment, speed, and predictability Deliver traceability and documentation gap analysis aligned to IEC 62304 6 months: Lead release of a major AI model or SaMD milestone on time Identify and implement 3 delivery optimisations that improve speed without sacrificing quality More ❯

develop, and maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough … Proficiency in Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity for an experienced embedded systems engineer join a fast More ❯

develop, and maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough … Proficiency in Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity for an experienced embedded systems engineer join a fast More ❯

ensuring the software in our medical technology meets the highest quality and regulatory standards. Responsibilities: Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software validation and verification (V&V) activities, including test planning, execution, and documentation. Collaborate with software engineers to … to software are effectively addressed and documented. Skills & Experience: Demonstrable experience in QA/RA for software in medical devices or a related field Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software Experience with software validation, V&V testing, and risk management (ISO 14971) Familiarity with software configuration More ❯

years' software engineering experience. Strong background in large, distributed systems design. Professional experience in C/C++ and Java. Demonstrable experience in safety-critical or safety-related environments (IEC 61508 ideal; IEC 62304 or IEC 26262 also acceptable). Strong working knowledge of software frameworks, languages, and toolchains. Understanding and practical use of Software FMEA. High More ❯

years' software engineering experience. Strong background in large, distributed systems design. Professional experience in C/C++ and Java. Demonstrable experience in safety-critical or safety-related environments (IEC 61508 ideal; IEC 62304 or IEC 26262 also acceptable). Strong working knowledge of software frameworks, languages, and toolchains. Understanding and practical use of Software FMEA. High More ❯

years' software engineering experience. Strong background in large, distributed systems design. Professional experience in C/C++ and Java. Demonstrable experience in safety-critical or safety-related environments (IEC 61508 ideal; IEC 62304 or IEC 26262 also acceptable). Strong working knowledge of software frameworks, languages, and toolchains. Understanding and practical use of Software FMEA. High More ❯

Minimum 5 years' software engineering experience. Experienced in large distributed system software design. Proficiency in C/C++ and Java. Significant experience with safety-critical or safety-related systems (IEC 61508 ideal/IEC 62304 or IEC 26262 desirable). Strong knowledge of high-integrity coding practices and tooling (unit test, static analysis, etc.) and software More ❯

Minimum 5 years' software engineering experience. Experienced in large distributed system software design. Proficiency in C/C++ and Java. Significant experience with safety-critical or safety-related systems (IEC 61508 ideal/IEC 62304 or IEC 26262 desirable). Strong knowledge of high-integrity coding practices and tooling (unit test, static analysis, etc.) and software More ❯

understanding QMS requirements. Engineering Excellence: Apply rigorous engineering practices, focusing on design reviews, decision-making, problem-solving, verification, risk management, and safety. Regulatory Compliance: Ensure adherence to standards like IEC 60601-1, IEC 60601-2-xx, IEC 62304, and necessary quality procedures for regulatory approvals. Cross-functional Collaboration: Foster relationships across R&D, PMO, product management … partners. Proven leadership in embedded Linux software and firmware development, preferably in medical devices. Experience with embedded electronic/software systems, communication technologies, software design, APIs, quality standards like IEC 62304. Background in product development within ISO 14971 quality systems, including approvals for EU-MDD, EU-MDR, and FDA. Flexible, adaptable, and capable of guiding teams through change in … a dynamic environment. Excellent communication skills, able to present to diverse stakeholders. Desirable Knowledge of IEC 60601 and AAMI EC standards for medical devices. What We Offer A challenging, innovative environment with competitive benefits tailored to your preferences. We value health, well-being, and personal growth, offering flexible schedules and health activities. More ❯

to design reviews, decision-making, problem solving and verification testing, with a strong focus on risk management and safety. Regulatory Compliance : Ensure adherence to relevant medical device standards (e.g., IEC 60601-1, IEC 60601-2-xx, IEC 62304) and quality procedures necessary for regulatory approvals. Cross-functional Collaboration : Foster strong working relationships across R&D, PMO … environment You are experienced in embedded electronic/software systems (including comms technologies like TCP/IP, ethernet, USB, WiFi, Bluetooth), software design, object-orientated design, APIs, software quality, IEC 62304. You have worked in product development within an ISO 14971 quality system (preferably including experience of product approvals for EU-MDD, EU-MDR and FDA). You have … your team through working within a dynamic environment You are a clear and concise communicator, with the ability to present to a broad range of stakeholders Desirable: Knowledge of IEC 60601 and AAMI EC medical device standards. In return, we offer you a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and More ❯

out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971 Software management Assignment and management of appropriate resources providing motivation, supervision and guidance of software engineering staff. The Software manager will have More ❯

out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971. Management of resources providing motivation, supervision and guidance of software engineering staff. Ensure adherence to current software design controls & processes. Collaborate with More ❯

out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971. Management of resources providing motivation, supervision and guidance of software engineering staff. Ensure adherence to current software design controls & processes. Collaborate with More ❯

support hardware integration. Work with RTOS (e.g., FreeRTOS, Zephyr) and bare-metal systems to deliver reliable and efficient solutions. Ensure compliance with industry standards (e.g., MISRA C, ISO 26262, IEC 62304) and create detailed technical documentation. Support system architecture discussions, contribute to design reviews, and drive improvements in coding standards, testing, and DevOps practices. Collaborate with cross-functional More ❯

ARM Cortex, STM32). Familiarity with RTOS, bare-metal, or embedded Linux environments. Professional experience utilising Docker containers. Experience with communication protocols (UART, SPI, I2C, USB). Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820. Strong understanding of software development lifecycle and version control (e.g., Git). Qualifications Bachelor's or Master's degree More ❯

senior engineer and will be expected to take on a high-impact technical role with responsibility for core embedded systems, while also contributing to production testing tools, validation against 62304, and unit/system testing. Most development is in Embedded C on STM32 platforms, with additional use of FPGAs for hardware mitigation and standardised UI display systems. While OEMs … Strong commercial experience in Embedded C development Experience working on STM32 or similar microcontroller platforms Exposure to FPGA-based systems or hardware mitigation techniques Familiarity with medical device standards (IEC 62304) or similar regulated environments Good communication skills, both within engineering teams and when interfacing with clients Experience developing production test software, test rigs, and performing unit/ More ❯

team DESIRABLE REQUIREMENTS: Use of schematic capture software Circuit analysis experience Knowledge of simulation packages Mathematical analysis skills Experience working within an ISO13485 or similar quality system Experience following IEC 62304 or similar Development of test harnesses and tools using C#/.NET. More ❯

tests across embedded and application-level systems. You'll work hands-on with hardware test setups, enhance CI-integrated test infrastructure, and support development, debugging, and documentation aligned with IEC 62304 standards. This role involves close collaboration with multidisciplinary teams to ensure quality, traceability, and compliance in both regulated and non-regulated projects. This is a full-time … to write structured, compliant documentation and communicate clearly. The ability to communicate your ideas and collaborate in broad project teams. Familiarity with medical or safety-critical standards such as IEC 62304. Experience with Git, Jira, Confluence, or equivalent tools. Experience with CppUTest, GTest and Doxygen. Comfort working across multiple layers of the stack, from hardware to application logic. Experience More ❯

Experience with embedded systems and test automation tools. Familiarity with CI/CD platforms and version control tools. Amazing to have: Experience with medical or safety-critical standards like IEC 62304. Knowledge of Git, Jira, Confluence, CppUTest, GTest, and Doxygen. Comfort working across software and hardware layers. Consultancy experience is a bonus. Please drop me a message if you More ❯

Experience with embedded systems and test automation tools. Familiarity with CI/CD platforms and version control tools. Amazing to have: Experience with medical or safety-critical standards like IEC 62304. Knowledge of Git, Jira, Confluence, CppUTest, GTest, and Doxygen. Comfort working across software and hardware layers. Consultancy experience is a bonus. Please drop me a message if you More ❯

Experience with embedded systems and test automation tools. Familiarity with CI/CD platforms and version control tools. Amazing to have: Experience with medical or safety-critical standards like IEC 62304. Knowledge of Git, Jira, Confluence, CppUTest, GTest, and Doxygen. Comfort working across software and hardware layers. Consultancy experience is a bonus. Please drop me a message if you More ❯

Experience with embedded systems and test automation tools. Familiarity with CI/CD platforms and version control tools. Amazing to have: Experience with medical or safety-critical standards like IEC 62304. Knowledge of Git, Jira, Confluence, CppUTest, GTest, and Doxygen. Comfort working across software and hardware layers. Consultancy experience is a bonus. Please drop me a message if you More ❯

Experience with embedded systems and test automation tools. Familiarity with CI/CD platforms and version control tools. Amazing to have: Experience with medical or safety-critical standards like IEC 62304. Knowledge of Git, Jira, Confluence, CppUTest, GTest, and Doxygen. Comfort working across software and hardware layers. Consultancy experience is a bonus. Please drop me a message if you More ❯