2 of 2 IEC 62304 Jobs in Hampshire

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 ❯

vision.Evaluate proposals from subsystem architects and external partners, while managing technical debt and prioritizing customer-centric non-functional requirements. Ensure software compliance with medical regulatory standards like FDA, MDR, IEC 62304 and ISO 13485.Maintain comprehensive documentation to support regulatory submissions, audits, and compliance reviews. Collaborate with global R&D teams and stakeholders in marketing, PMO, quality, regulatory, and … devices to market and leading teams in multiple product launches. Your skills include a strong background in clinical applications, systems integration, interoperability, and knowledge of medical device regulations like IEC 62304, FDA, MDR, and ISO 13485.You are familiar to work in agile development methodologies like SAFe, apply AI/ML technologies, and are able to solve problems using More ❯