9 of 9 IEC 62304 Jobs in the South East

software subsystems. Engineering Excellence: Apply rigorous engineering practices in reviews, decision-making, problem-solving, and verification, emphasizing risk management and safety. Regulatory Compliance: Ensure compliance with medical device standards (IEC 60601 series, IEC 62304) and quality procedures for regulatory approvals. Cross-functional Collaboration: Foster relationships across R&D, PMO, product management, operations, regulatory, and quality teams, especially … preferred, but other regulated industries considered. Experience leading embedded Linux software development. Knowledge of embedded electronic/software systems, communication technologies (TCP/IP, Ethernet, USB, WiFi, Bluetooth), APIs, IEC 62304. Experience within ISO 14971 quality systems and product approvals (EU-MDD, EU-MDR, FDA). Flexible, adaptable, and open to change in a dynamic environment. Excellent communication skills 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 to join a fast-growing MedTech company at the 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 to join a fast-growing MedTech company at the More ❯

science-based engineering practices during design reviews, decision-making, problem solving, and verification testing, emphasizing 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 for regulatory approvals. Cross-functional Collaboration: Foster strong relationships across R&D, PMO, product management … You are experienced with embedded electronic/software systems, including communication technologies like TCP/IP, Ethernet, USB, WiFi, Bluetooth, software design, object-oriented programming, APIs, software quality, and IEC 62304. You have worked within an ISO 14971 quality system, including experience with product approvals for EU-MDD, EU-MDR, and FDA. You demonstrate flexibility, adaptability, and a willingness 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. #LI-EU #LI-Office #J-18808-Ljbffr 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 ❯

in an IVD environment along with practical experience in working to applicable management standards (i.e. ISO 13485). Experience with and demonstrable understanding of some of the following: IEC14971, IEC 62304, IEC 62366, GLP, EMC (IEC61326), IEC61010-1, packaging/transport standards, labelling standards and IVDR performance evaluation requirements Desirable: Experience of leading (from the manufacturer side More ❯

and CAPA activities, with a solid understanding of QMS. Engineering Excellence: Apply rigorous engineering practices focusing on risk management and safety. Regulatory Compliance: Ensure adherence to relevant standards like IEC 60601-1, IEC 60601-2-xx, IEC 62304, and quality procedures for regulatory approvals. Cross-functional Collaboration: Foster relationships across R&D, PMO, product management, operations … collaboration with partners. Proven experience leading software and firmware development in embedded Linux, preferably in medical devices. Knowledge of embedded electronic/software systems, communication technologies, software design, APIs, IEC 62304. Experience within an ISO 14971 quality system, including product approvals for EU-MDD, EU-MDR, and FDA. Flexible attitude, capable of guiding teams through dynamic environments. Clear and … concise communication skills for stakeholder presentations. 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 local health activities. #LI-EU #LI-Office #J-18808-Ljbffr More ❯

England, United Kingdom 1 week ago BUILDING SERVICES - Junior Mechanical Project Manager Winnersh, England, United Kingdom 3 months ago Remote Senior Risk Management Engineer, Medical Devices (ISO 14971/IEC 60601/IEC 62304) 12 months Fixed Term contract bei Vision RT Surrey, England, United Kingdom 1 month ago We’re unlocking community knowledge in a new More ❯