10 of 10 IEC 62304 Jobs in the UK excluding London

Solid understanding of analogue design, low-noise circuitry, and PCB layout. Experience with BLE or Wi-Fi and associated regulatory workflows. Familiarity with medical or regulated environments (ISO 13485, IEC 60601, IEC 62304). This is a unique opportunity to join a forward-thinking company developing next-generation connected healthcare technology. Youll work alongside a passionate team 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 ❯

medical device development. Familiarity with ISO 14971 & ISO 13485. Strong understanding of system-level requirements and V&V principles. Desirable: Experience with implantable or active medical devices. Knowledge of IEC 60601, IEC 62304, or ISO 14708. Proficiency with document control and requirements management tools. Experience working with clinical and academic partners. Whats on Offer Competitive salary based 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 ❯

transfer of the product from design to manufacturing, solving engineering issues in electronics, firmware, and production instrumentation Maintain, adapt, and optimise existing firmware within the constraints of regulatory compliance (IEC 62304, ISO 13485) Lead electronics design, schematic capture, and PCB layout using Altium Develop LabVIEW applications for test and instrumentation Collaborate with manufacturing partners to troubleshoot and resolve More ❯

auditing experience Desirable Criteria (what you will learn at Sonrai!) ● Experience working in a certified ISO Quality Management System, such as ISO 9001, ISO 13485 certified QMS with EN 62304, ISO 14971 product development standards ● US data protection legislation experience ● Knowledge/awareness of the AI Act and vulnerability management processes ● Awareness of AWS as cloud infrastructure ● EU IVDR More ❯

auditing experience Desirable Criteria (what you will learn at Sonrai!) ● Experience working in a certified ISO Quality Management System, such as ISO 9001, ISO 13485 certified QMS with EN 62304, ISO 14971 product development standards ● US data protection legislation experience ● Knowledge/awareness of the AI Act and vulnerability management processes ● Awareness of AWS as cloud infrastructure ● EU IVDR More ❯

auditing experience Desirable Criteria (what you will learn at Sonrai!) ● Experience working in a certified ISO Quality Management System, such as ISO 9001, ISO 13485 certified QMS with EN 62304, ISO 14971 product development standards ● US data protection legislation experience ● Knowledge/awareness of the AI Act and vulnerability management processes ● Awareness of AWS as cloud infrastructure ● EU IVDR More ❯

defense, aerospace, etc.) is a plus. Experience in product development of medical devices under Design Control (21 CFR Part 820) and ISO 14971 and developing to and compliance with IEC62304 is a big plus. Experience in the development of integrated (hardware and software) devices. Experience with scripting languages (e.g., Bash, PowerShell). Experience with Containerized environments and virtual machines Experience More ❯