19 of 19 IEC 62304 Jobs in England

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 ❯

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 ❯

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 ❯

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 ❯

Experience with cybersecurity and cryptographically protected communication channels Knowledge about implementation of BLE systems for secure and robust communications Experience developing embedded systems for early-stage medical devices under IEC 60601, 62304, and ISO 13485 Notice By submitting your application, you acknowledge that Motif Neurotech will process your personal data for recruitment purposes. This includes evaluating your qualifications … exempt, salaried US employees Please click here to apply. Tagged as: ARM Cortex-M medical device job , BLE firmware developer medical , embedded firmware engineer healthcare , embedded systems engineer London , IEC 62304 embedded systems , Motif Neurotech careers , neural interface systems engineer , neurotech firmware jobs UK , regulated embedded systems jobs UK , wireless brain stimulator engineer 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 ❯

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 ❯

essential. If you're confident facilitating, coaching, and communicating across teams, you'll fit right in. You'll also need to be familiar with regulatory standards like ISO 13485, IEC 62304, and FDA's 21 CFR Part 820. Experience working on products that combine hardware and software is important, especially if you've delivered medical device software that … complies with IEC 62304. And finally, if you've had experience developing compliant processes and presenting project updates to executive leadership, that will help you stand out. You. Unlimited We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and More ❯

Publish-Subscribe pattern Experience of working with Jira, BitBucket and Git Experience in working within a regulated SDLC process (optional but advantageous) Experience in working in MedTech, including ISO 62304 (optional but advantageous) Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS More ❯

SaMD product through certification under UK MDR You're highly self-starting, proactive, and comfortable working autonomously You have deep knowledge of UK MDR and strong working familiarity with IEC 62304, ISO 14971, and ISO 13485 You've worked in fast-moving digital health teams and can balance regulatory compliance with the realities of iterative product development You More ❯

analytical and structured approach, and a great ability to work with people across the business. You'd be responsible for: Knowing the ISO standards applicable to us (13485, 14971, 62304, 82304 in particular) and understanding how they map onto day-to-day Flok activities and tools. Helping us design, implement, and improve processes for meeting the requirements. Working closely More ❯

minded RA/QA Senior Specialist with deep expertise in Software as a Medical Device (SaMD) and artificial intelligence (AI) regulatory frameworks, including the EU AI Act, ISO/IEC DIS 42001 (AI Management System), ISO/IEC 23894 (AI Risk Management), BS 30440:2023 (Validation framework for AI in healthcare), and MHRA guidance on Software and AI … alignment with evolving global standards and supporting innovation in regulated software development. Provide strategic oversight for interpreting and implementing regulatory frameworks such as the EU AI Act, ISO/IEC DIS 42001, ISO/IEC 23894, BS 30440:2023, ensuring comprehensive alignment with ethical, technical, and compliance considerations specific to AI and LLM applications in SaMD. Drive the … complex regulations into clear, strategic actions for cross-functional teams. Software Development Lifecycle: Provide strategic leadership over the software development and release management process, ensuring comprehensive compliance with ISO 62304 and ISO 13485. Collaborate closely with engineering leadership to ensure that software modifications and updates adhere rigorously to regulatory and quality expectations before approval and deployment. Lead and refine More ❯