18 of 18 Permanent IEC 62304 Jobs in the UK excluding London

early concept through product release Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971.Act as the firmware compliance leader, guiding the team on requirements management, traceability, risk control implementation, verification strategy, and evidence … products that have reached clinical, commercial, or regulatory submission stages Demonstrated experience working within an ISO 13485certified Quality Management System. Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied to software Strong embedded programming skills in C and experience ...

another regulated industry (e.g. aerospace, automotive safety, or similar safety-critical sectors) Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304, IEC 60601, or equivalent A strong grasp of the documentation, traceability, and verification rigour required for regulated, safety-critical software development ...

software architecture across the medical device platform Lead technical decision-making across Software, Signal Processing and Firmware interfaces Ensure software development aligns with IEC 62304 and wider medical device requirements Support regulatory submissions and the progression of products towards commercial release Provide technical guidance to internal engineers, contractors … troubleshooting Experience & Skills Required Extensive software engineering experience within regulated medical devices Principal, Lead, Architect or equivalent senior technical experience Strong knowledge of IEC 62304 and the medical device software development lifecycle Strong software architecture and systems-level engineering experience Broad technical understanding across software, embedded/firmware ...

traveling 5% to 10% of your time to different locations mainly within Europe. Beneficial Qualifications: Familiarity with healthcare/MedTech software regulatory standards (IEC 62304, ISO 13485, ISO 14971, IEC 81001-5-1). Experience with threat modeling, secure data handling, design controls, and regulatory submission documentation. ...

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 ...

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 ...

containers + Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join ...

within a regulated product development environment, ideally medical devices. Experience working within structured development processes covering requirements, traceability, risk management, testing and V&V. IEC 62304 and/or ISO 13485 experience would be highly advantageous. This is a fantastic opportunity to join a growing MedTech business ...

practical experience Some Skills that will differentiate you: Jira administration — boards, workflows, dashboards, reporting Formal business analysis technique and documentation standards Nice-to-have: IEC 62304, ISO 13485 or ISO 14971 exposure; SaMD experience PSPO, CSPO, PSM/CSM, BCS/CBAP/PMI-PBA, or ISTQB Foundation ...

assess whether software has been adequately verified within a formal development lifecycle. Experience developing and/or verifying safety-critical software to standards including IEC 61508, ISO 26262, DO-178B/C or IEC 62304, with knowledge of ASPICE and MISRA. Strong embedded software and systems expertise ...

assess whether software has been adequately verified within a formal development lifecycle. Experience developing and/or verifying safety-critical software to standards including IEC 61508, ISO 26262, DO-178B/C or IEC 62304, with knowledge of ASPICE and MISRA. Strong embedded software and systems expertise ...

will save lives all around the world. It is essential that you have medical devices knowledge working within ISO 13485, EN 60601, IVDD or IEC 62304 standards. You will essentially have Embedded C programming along with C#, C++ and Java. As this company is growing there ...

including genomic, molecular and software-based diagnostics. Experience with Software as an IVD (SaMD) and an understanding of software lifecycle and validation requirements (e.g. IEC 62304). Strong understanding of design control, product lifecycle management and regulatory change management. Hands-on experience with Risk Management in accordance with ...

this cutting-edge medical device. Ideally, you will have worked within the Medical Devices sector previously and have good knowledge of ISO 13485, IEC 62304 and ISO 14971.The company has the unique ability to offer an excellent benefits package, unusual for a start-up, including pension, shares, medical ...

happy to work closely with developers. You’ll also be interested in the full development lifecycle and in working to standards like IEC 62304. Your skills and experience Whilst you do not need to meet all of these points, please ensure you meet the majority within your specialism before ...

PACS. You will define interoperability architecture and lead cross-functional teams in a medical device context. The role requires deep clinical software experience, IEC 62304 expertise, and hands-on leadership in delivering safe, compliant medical software across complex workflows. #J-18808-Ljbffr ...

with algorithm design and implementation Understanding of software architecture, diagnostics and system logging Experience with software update/upgrade mechanisms Strong knowledge of the IEC 62304 software lifecycle process Experience with ISO 14971 risk management Experience producing and working with regulated software documentation A structured and quality-focused ...

with Git-based version control and unit test frameworks such as GoogleTest Some experience of working on medical software development, in particular knowledge of IEC 62304 would be useful. Experience in another highly regulated industry may be applicable. Not essential, but we would value experience using ...