26 to 50 of 56 IEC 62304 Jobs in England

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 ❯

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 ❯

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 new product development • Strong experience developing complex software or electromechanical medical devices • Excellent understanding of design controls and good documentation practices • Experience in applying regulatory standards to products (IEC 60601, 14971, 62366, 62304, ISO 13485 or aerospace equivalents) • Willingness to be on-site (minimum 2 -3 days/week in London office) Nice to Haves • Experience with More ❯

QARA Software Specialist Location: London (on-site 4 days/week) Salary: Dependent on experience + benefits Responsibilities Develop, implement, and maintain software QA processes compliant with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software validation and verification activities, including test planning, execution, and documentation. Collaborate with software engineers to ensure SDLC … and document non-conformances, CAPAs, and audits related to software. Skills & Experience Experience in QA/RA for medical device software or related fields. Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations. Experience with software validation, V&V testing, and risk management (ISO 14971). Familiarity with configuration management, cybersecurity 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 ❯

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. #LI-EU #LI-Office #J-18808-Ljbffr 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 ❯

AWS), Microsoft Azure, Google Cloud Platform (GCP), etc. Proficiency in version control systems such as Git Knowledge of data and cloud security Knowledge of software international standards such as IEC 62304, IEC 62366, ISO/IEC 12207, and ISO/IEC 27001, etc. Desirable Experience in communicating over Bluetooth Low Energy (BLE) (version 5.0 + 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 ❯

infrastructure such as directory services (LDAP/NIS), authentication protocols (such as Okta, OAuth, OpenID, etc.) is desired. Experience with software development methodologies such as Agile, SDLC as per IEC62304 is desired. Experience with end-to-end DevOps (from requirements to implementation to production to operations) tools such as Azure DevOps, GitHub, etc. is desired. Possess an understanding of Risk More ❯

Software Engineer, Quality, IEC 62304, ISO 13485, Medical Devices, COR7184 A rare and exciting opportunity has arisen for a Software Engineer with experience working with software as a medical devices and IEC 62304 standards, to join a pioneering scientific R&D company specialising in the development of medical devices. The Role The Software Engineer will take … innovative In Vitro Diagnostic products. Working alongside a highly skilled team, you’ll be responsible for implementing and maintaining SDLC processes, software risk management, and compliance with ISO 13485, IEC 62304, and 21 CFR Part 820. This is a fantastic opportunity to make a significant impact in a fast-growing company at the forefront of medical technology. The … of the Software Engineer? Experience defining, implementing, and maintaining Software Development Life Cycle (SDLC) processes Proven experience in software quality engineering and risk management Strong knowledge of ISO 13485, IEC 62304, 21 CFR Part 820, IVDR Experience in software security risk management (SW:96:2023, ISO 27001, IEC 80001) is a plus What Next? If you’re 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 ❯

and CAPA activities, with a solid understanding of QMS. Engineering Excellence: Apply rigorous engineering practices focusing on risk management and safety. Regulatory Compliance: Ensure adherence to relevant standards like IEC 60601-1, IEC 60601-2-xx, IEC 62304, and quality procedures for regulatory approvals. Cross-functional Collaboration: Foster relationships across R&D, PMO, product management, operations … collaboration with partners. Proven experience leading software and firmware development in embedded Linux, preferably in medical devices. Knowledge of embedded electronic/software systems, communication technologies, software design, APIs, IEC 62304. Experience within an ISO 14971 quality system, including product approvals for EU-MDD, EU-MDR, and FDA. Flexible attitude, capable of guiding teams through dynamic environments. Clear and … concise communication skills for stakeholder presentations. 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 local health activities. #LI-EU #LI-Office #J-18808-Ljbffr More ❯

management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable skills: Work experience - Experience working with ISO 27001 Analytical reader - You More ❯

management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable Skills Work experience - Experience working with ISO 27001 Analytical reader - You More ❯

anomaly 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 ❯

representative and welcoming environment, for everyone. Your skills and experience Preferred • Siemens Polarion certification(s) • Experience in regulated industries (Medical Device, Automotive, Aerospace) • Knowledge of compliance standards (ISO 13485, IEC 62304, FDA CFR 21 Part 11, ASPICE, etc.) • Experience with Polarion's REST API and XML-based configuration • Familiarity with CI/CD tools and DevOps practices • Experience More ❯

critical systems, such as aerospace, automotive, or medical devices. Familiarity with software testing, static analysis, or compliance tools. Knowledge of industry standards such as ISO 26262, DO-178C, or IEC 62304. Ability to speak a second language is a plus. Why Join Represent a highly respected suite of solutions used by leading organizations worldwide to improve software quality and 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 ❯

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 ❯

Develop robust and efficient algorithms for real-time data analysis and image processing Contribute to algorithm performance testing design and implementation Implement SaMD design control process in alignment with IEC 62304's software lifecycle processes Qualifications Required: Degree in Computer Science, Biomedical Engineering, or related field Experience with real-time processing systems Experience in AI/ML or More ❯

skills and demonstrable experience in test automation (preferably Python and Kotlin). Experience with virtualization, Linux, and remote device management. Knowledge of medical device regulations and standards (ISO 13485, IEC 62304, 21 CFR 820). Nice to Haves: BS/MS in Computer, Electrical, Electronics Engineering or equivalent industry experience. Advanced certification in software testing and modern quality 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 ❯