14 of 14 Remote IEC 62304 Jobs in England

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 ❯

ensuring the software in our medical technology meets the highest quality and regulatory standards. Responsibilities: Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software validation and verification (V&V) activities, including test planning, execution, and documentation. Collaborate with software engineers to … to software are effectively addressed and documented. Skills & Experience: Demonstrable experience in QA/RA for software in medical devices or a related field Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software Experience with software validation, V&V testing, and risk management (ISO 14971) Familiarity with software configuration 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 ❯

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 ❯

detection). Proficient in Python and ML frameworks such as PyTorch or TensorFlow. Familiarity with FDA regulatory pathways for medical software (e.g., 510(k), De Novo), and standards like IEC 62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Preferred Qualifications: Experience building ML models with wearable data (e.g., continuous heart rate, motion 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 ❯