23 of 23 IEC 62304 Jobs in London

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 ❯

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 ❯

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 ❯

Development Life Cycle (SDLC) for both products and internal tools Verification and Validation: Lead formal Software Verification and Validation (V&V) activities, ensuring adherence to industry standards such as IEC 62304, ISO 14971, IEC 62366, ISO 13485, and FDA regulations, including cybersecurity requirements Process Improvement: Drive continuous improvement by enhancing automation, adopting innovative testing techniques, and optimizing More ❯

Experience with cybersecurity and cryptographically protected communication channels Knowledge about implementation of BLE systems for secure and robust communications Experience developing embedded systems for early-stage medical devices under IEC 60601, 62304, and ISO 13485 Notice By submitting your application, you acknowledge that Motif Neurotech will process your personal data for recruitment purposes. This includes evaluating your qualifications 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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

in signal processing and time-series modelling. Proficiency in Python and ML frameworks such as PyTorch or TensorFlow. Familiarity with FDA regulatory pathways for medical software and standards like IEC 62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Robert Walters Operations Limited is an employment business and employment agency and welcomes applications More ❯

performance metrics alongside error diagnostics. Preferred Experience in a regulated industry (e.g. Banking, Medical) Experience with Data Residency requirements Experience with SOC2, ISO 27001 Experience with development compliant to IEC62304 About us All the health information we need is within us. Just below the skin. SAVA is redefining the way people interact with their health by developing the most advanced More ❯

experience in medical device Quality Management Systems and regulatory processes including ISO 13485, ISO 14971, ISO 27001, 21 CFR Part 11, 21 CFR Part 820, MDR 2017/745, IEC 62304. Proven track record in interactions with Notified Bodies and/or Regulatory Authorities, especially the FDA. Knowledge of UK, US and/or EU Data Protection Regulations (i.e. More ❯

understand requirements to work on new and exciting features. Define, document and implement comprehensive unit and functional tests for each one of the app components. Write code following the IEC62304 based software development lifecycle. Challenge yourself and others, learn new technologies, and have fun! What you should bring to Acurable Bachelor’s or Master’s degree in Engineering, Computer Science More ❯