10 of 10 IEC 62304 Jobs in England

and the Regulatory team, to develop safe and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, IEC 13485, and FDA regulations, including cybersecurity requirements Implementation & Compliance: Develop software solutions and support cross-functional development activities, ensuring adherence More ❯

desktop application development. The ideal candidate is a hands-on technical leader with experience in system-level design, cloud computing, and cybersecurity, particularly within FDA-regulated medical device software (IEC 62304, cybersecurity compliance). Key Responsibilities: System Architecture & Technical Leadership: Design, develop, and optimize scalable, secure, and compliant software solutions for medical devices and connected health applications. Ensure … adherence to IEC 62304, FDA, and cybersecurity regulations, addressing threat modeling, secure coding practices, and risk management. Work with cross-functional teams to architect cloud solutions, ensuring performance, scalability, security, and compliance. Implement cloud-native architecture, microservices, and containerization (Docker, Kubernetes). Deploy and manage Azure Cloud applications, ensuring reliability and efficiency. Implement DevOps practices, cloud storage solutions … intuitive and visually appealing user interfaces. Integrate mobile apps with cloud services and APIs, ensuring seamless data flow. Cybersecurity & Compliance Ensure secure software development practices in compliance with FDA, IEC 62304, and ISO 27001. Implement identity management, authentication, and data encryption strategies. Conduct threat modeling, vulnerability assessments, and penetration testing. Address cybersecurity challenges in connected medical devices and 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 ❯

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 ❯

GTK, and CMake. Experience in designing and implementing graphical user interfaces. Competence in writing well-tested and testable code. Understanding of software development in regulated industries, especially medical (e.g., IEC 62304 compliance). Strong communication skills, with the ability to explain technical concepts to non-technical stakeholders. Capable of working independently, prioritising tasks, and meeting project deadlines. Willingness More ❯

US market entry. Documentation & Submissions: Prepare and maintain regulatory submissions and documentation including Declarations of Conformity, Technical Files and labelling reviews. Ensure documentation is in compliance with ISO 13485, IEC 62304, ISO 14971, and other applicable standards. Risk Management: Lead and coordinate risk management activities in accordance with ISO 14971, integrating risk assessments throughout the product development and … for improving lives through assistive technology. Strong working knowledge of UK MDR, EU MDR, and FDA medical device regulations. Familiarity with technical standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series. Experience with Class I medical devices and SaMD regulatory requirements. Excellent documentation and communication skills – able to communicate clearly and concisely in More ❯

in Manchester, focused on developing innovative molecular diagnostic solutions that improve patient outcomes worldwide. Certified to ISO 13485:2016 and operating in compliance with BS EN ISO 14971 and IEC 62304, Genedrive is dedicated to meeting the highest standards in medical technology. With a strong collaborative culture and a mission to make diagnostics more accessible and efficient, Genedrive … and ISO 14971 Experience with internal/external audits and training delivery Excellent analytical, organisational, and communication skills Comfortable working independently and within cross-functional teams Desirable: Knowledge of IEC 62304, ISO 60601, and global radio regulations Experience with global medical device regulations particularly UK, EU and USA Familiarity with the commercialisation of IVD products ISO More ❯

and maintain robust Python applications for medical device software Collaborate with cross-functional teams, including R&D, product management, and QA Ensure software meets regulatory standards (e.g., ISO 13485, IEC 62304) for medical devices Write clean, efficient, and well-documented code following best practices Participate in code reviews, testing, and continuous improvement initiatives Requirements: Strong experience in Python 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 ❯