2 of 2 Permanent IEC 62304 Jobs in Farnborough

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 ❯