1 to 25 of 68 IEC 62304 Jobs in the UK

design, development, risk assessment, and change control. They will provide Quality and Design Assurance oversight across the software lifecycle for medical devices, including IEC 62304 software and digital health applications. The role works closely with Regulatory Affairs to ensure software documentation and procedures meet applicable standards and regulatory … Assure software quality throughout the full lifecycle process in accordance with OrganOx software standards and procedures for software up to safety class C per IEC 62304. Ensure effective implementation of software design controls, including requirements, architecture, verification and validation, configuration management, change control and release management. Ensure appropriate traceability ...

device validation and compliance. The work could involve partnering with cross-functional teams to design, execute and document validation activities under ISO 13485 and IEC 62304, with scope to contribute to delivering devices that meet the highest regulatory standards. Typical role overview Location: London, Greater London, England Type … responsibilities could include: Supporting the design and execution of system validation protocols and test cases Conducting validation testing and documenting results in compliance with IEC 62304 and ISO 13485 Coordinating with engineering, quality and regulatory teams to ensure validation completeness Preparing validation reports and supporting regulatory submissions Contributing ...

device validation and compliance. The work could involve partnering with cross-functional teams to design, execute and document validation activities under ISO 13485 and IEC 62304, with scope to contribute to delivering devices that meet the highest regulatory standards. Typical role overview Location: London, Greater London, England Type … responsibilities could include: Supporting the design and execution of system validation protocols and test cases Conducting validation testing and documenting results in compliance with IEC 62304 and ISO 13485 Coordinating with engineering, quality and regulatory teams to ensure validation completeness Preparing validation reports and supporting regulatory submissions Contributing ...

controls through objective evidence. Experience working in regulated development environments (CE, UKCA, FDA). Knowledge of medical device standards and their implications for verification (IEC 60601, IEC 62304, IEC 62366). Experience with test automation and tooling for repeatable verification (CI pipelines, Python‐based test rigs ...

controls and lifecycle management. Experience managing electronic component obsolescence or component changes. Working knowledge of relevant standards and regulations, including: ISO 14971 ISO 13485 IEC 60601 series IEC 62304 IEC 62366 EU MDR, UK MDR or applicable FDA requirements. Experience contributing to Design History Files, technical ...

build and oversee efficient, well-tested, production-ready data pipelines, models and analyses, within a compliant software development lifecycle (GAMP 5 and IEC 62304) and in line with our Quality Management System (QMS).The role combines data engineering, statistical analysis, applied data science and technical leadership. … reports for technical and non-technical audiences Quality & compliance Follow and help uphold the software development lifecycle in line with GAMP 5 and IEC 62304, including planning, design, verification and validation Produce and maintain software and analysis documentation, including requirements, design, traceability and verification records Make sure development ...

full software development lifecycle, including requirements definition, architecture, implementation, testing, and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, and other relevant safety standards. Establish and enforce high-quality software engineering practices, including code reviews, architectural governance, and design best practices. … tools to accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

firmware integration Carry out regression testing and release verification for a product on the market under design controls, in accordance with applicable standards including IEC 62304 and ISO 14971 Work with the Quality team to maintain traceability from verification to requirements and risk management, and to document test … extending a test harness Ability to communicate technical information clearly and to work well with engineers across disciplines Desirable skills and experience: Familiarity with IEC 62304 and ISO 14971, or equivalent standards in another regulated industry Hardware‐in‐the‐loop or test‐rig experience, including firmware‐level testing ...

research groups can say. It should become a gate a method passes, not an event that consumes weeks. Regulatory evidence as a by-product. IEC 62304 traceability artefacts generated from CI rather than written alongside it. Growing the capability. Mentoring junior developers in the team, and shaping this … road early and widening it, rather than designing the complete platform first Nice to have: Regulated environment experience (medical devices, diagnostics, pharma, aerospace), particularly IEC 62304 or software as a medical device Time-series or signal processing workloads, physiological data, or scientific instrumentation Experiment tracking, model registries ...

paced startup environment. Greatly Beneficial Safety-Critical Verification: Experience verifying safety-critical or high-reliability systems — especially under standards such as ISO 26262 (automotive), IEC 61508 (industrial), or medical device standards (ISO 13485/IEC 60601/IEC 62304) — including fault injection and requirements traceability. Mixed ...

identify meaningful safety risks Excellent written and verbal communication skills Preferred Knowledge or formal training in relevant medical device software standards, such as IEC 62304 and IEC 81001-5-1 Experience with medical device software certification, assessment, auditing or regulatory processes Experience with generative AI, including LLMs ...

cybersecurity Exceptional written and verbal communication skills Preferred qualifications Knowledge or training in the relevant standards and guidance for medical device software, such as IEC 62304 and IEC 81001-5-1 Practical experience with generative AI e.g. LLMs, embeddings, RAG, fine-tuning, evaluation/monitoring Interview with ...

designs using Altium Designer (advantageous). Performing component selection and design calculations to meet performance specifications. Conducting design verification and validation in accordance with IEC 60601 and other applicable standards. Collaborating with mechanical, software, and systems engineers to ensure seamless integration of electronics. Supporting prototype assembly, debugging, and troubleshooting. … design-for-manufacture principles. Experience with electronic testing tools such as oscilloscopes, spectrum analysers, and logic analysers. Understanding of medical device standards (ISO 13485, IEC 60601, IEC 62304) is an advantage. Ability to troubleshoot and solve complex design issues. Effective communication skills for working within cross-functional ...

development, and verification of electronic systems for Class III medical devices. Defining electronic architecture and component selection to meet performance, safety, and regulatory requirements (IEC 60601, IEC 62304, ISO 14971). Reviewing and approving schematics, PCB layouts, and technical documentation. Supporting system-level architecture decisions, particularly … regulated products (medical device experience strongly preferred). Strong background in both analogue and digital circuit design. Proven track record of designing to IEC 60601 and other relevant safety standards. Experience with PCB design tools (e.g., Altium Designer) and version control systems. Knowledge of power electronics, motor control ...

medical devices. The ideal candidate brings deep hands-on experience with DICOM-RT standards, network-level system integration, and medical device software development under IEC 62304. You will play a key technical leadership role in defining and implementing the interoperability architecture that connects our treatment delivery system … lead on significant software development projects spanning interoperability and clinical connectivity. Write specifications, requirements, design documents, and test protocols for software projectsin accordance withIEC 62304 and thecompanydesign control process. Develop safety-critical software for imaging and treatment delivery systems. Work with external partners and clinical customers to develop,validate ...

findings clearly to varied audiences. Ability to meet the security vetting requirements applicable to individual assignments. Experience with any of the following is desirable: IEC 61508 for functional safety of electrical, electronic and programmable electronic safety-related systems. ISO 26262 for automotive functional safety. EUROCAE ED-12C/RTCA … system development and safety assessment. DEF STAN 00-55 and DEF STAN 00-56 for safety-related software and defence system safety management. IEC 62304 for medical device software lifecycle processes. EN 50126, EN 50128 and EN 50129 for railway reliability, availability, maintainability and safety, software and safety ...

findings clearly to varied audiences. Ability to meet the security vetting requirements applicable to individual assignments. Experience with any of the following is desirable: IEC 61508 for functional safety of electrical, electronic and programmable electronic safety-related systems. ISO 26262 for automotive functional safety. EUROCAE ED-12C/RTCA … system development and safety assessment. DEF STAN 00-55 and DEF STAN 00-56 for safety-related software and defence system safety management. IEC 62304 for medical device software lifecycle processes. EN 50126, EN 50128 and EN 50129 for railway reliability, availability, maintainability and safety, software and safety ...

bids, methodologies, and capability development initiatives. Relevant Standards & Guidance We recognise that candidates may have experience in some rather than all of the following: IEC 61508 – Functional safety of electrical, electronic, and programmable electronic safety-related systems. ISO 26262 – Functional safety for road vehicles. EUROCAE ED-12C/RTCA … Aircraft and system development and safety assessment. DEF STAN 00-55 and DEF STAN 00-56 – Safety-related software and defence system safety management. IEC 62304 – Medical device software lifecycle processes. EN 50126, EN 50128, and EN 50129 – Railway RAMS, software, and safety-related electronic systems. IEC ...

technical stakeholders. Desirable Experience supporting software products through regulatory submissions, inspections, audits, or product approvals. Familiarity with standards and regulations such as IEC 62304, ISO 13485, FDA software guidance, EU IVDR, IEC 81001-5-1, or comparable industry frameworks. Familiarity with secure software development practices, vulnerability management ...

systems design and development Proficiency in C and assembler. strong experience with Real-Time Operating Systems Familiarity with safety-critical software development standards (e.g., IEC 61508, DO 178B/C, ISO26262, IEC 62304) Experience in software development within a controlled development environment Low-level embedded engineering experience ...

future product development, influencing firmware architecture and technical decisions. Ensuring firmware is developed, tested and documented to meet medical device regulatory requirements, including IEC 62304. Building the foundations for bringing firmware development in-house. Contributing hands‐on to development, debugging, testing and problem‐solving. Collaborating with electronics, software, quality … regulated products, ideally in medical devices or aerospace/aviation . An understanding of structured software development, verification, traceability and regulatory documentation. Experience with IEC 62304 or DO‐178C would be particularly relevant. Knowledge of low‐power, battery‐operated devices and Bluetooth Low Energy (BLE). The confidence ...

future product development, influencing firmware architecture and technical decisions. Ensuring firmware is developed, tested and documented to meet medical device regulatory requirements, including IEC 62304. Building the foundations for bringing firmware development in-house. Contributing hands‐on to development, debugging, testing and problem‐solving. Collaborating with electronics, software, quality … regulated products, ideally in medical devices or aerospace/aviation . An understanding of structured software development, verification, traceability and regulatory documentation. Experience with IEC 62304 or DO-178C would be particularly relevant. Knowledge of low‐power, battery‐operated devices and Bluetooth Low Energy (BLE). The confidence ...

hybrid role with some remote work. The ideal candidate has a Computer Science background, embeds systems experience, and familiarity with ISO 13485, IEC 62304 and FDA requirements. #J-18808-Ljbffr ...

engineering practices Background in Computer Science and Software Development Experience in embedded systems development Knowledge of regulatory standards for medical software, including ISO 13485, IEC 62304, and FDA requirements Proficiency in programming and object-oriented programming (Python, C#, C++) Knowledge of software testing and verification techniques Strong problem ...

verbal communication, teamworking, and problem-solving skills, plus a good understanding of software engineering best practices such as version control with Git. Experience with IEC 62304 would be a bonus Full existing UK work permission without time limit or sponsorship Projects will be varied and challenging, providing long ...