1 to 25 of 38 IEC 62304 Jobs in the UK

decisions Drive software from prototype through to production release, managing dependencies with the FPGA, electronics, optical, and clinical teams Ensure software development complies with IEC 62304 (Class C), IEC 60601-1, and ISO 14971, maintaining documentation and traceability in line with CoMind's QMS Partner with … physiological data pipelines Familiarity with CUDA or GPU-accelerated processing pipelinesExperience with Flutter/Dart or other embedded GUI frameworks Working knowledge of IEC 62304, IEC 60601-1, and ISO 14971 Experience with FPGA-software interfaces or hardware abstraction layers Familiarity with Yocto-based embedded Linux ...

Your core mission is to help ensure that our software design and development activities meet global medical device requirements, leading the practical implementation of IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management systems) within an agile, iterative environment. You’ll help shape … Drive Medical Device Design Control Processes Lead the implementation and continuous improvement of design control processes across the software lifecycle in alignment with IEC 62304, ISO 14971, and ISO 13485. Partner with engineers and product managers to ensure requirements, risk controls, verification, and validation activities are clearly defined ...

engineering team with high-velocity, high-confidence validation. You will serve as a key technical authority, ensuring our software not only meets stringent IEC 62304 and ISO 14971 standards but does so through sustainable, automated design. You will function as the technical authority for software quality. Your goal … proven track record of architecting testing strategies for complex, regulated systems (embedded, real-time, or SaMD). Regulatory & Risk Authority: Deep working knowledge of IEC 62304 and ISO 14971. Proven ability to design 'compliance-as-code' workflows that integrate risk controls directly into the CI/CD pipeline ...

building infrastructure for continuous validation and championing design for testability across the engineering stack Establish compliance-as-code workflows that map verification evidence to IEC 62304 (Class C) and ISO 14971 risk controls, maintain the high-bar for engineering excellence in a regulated safety-critical environment and automate … spanning embedded hardware and cloud-side data pipelines Experience delivering in a regulated industry (medical devices, aerospace, automotive, or similar), with working knowledge of IEC 62304 and ISO 14971 Advanced Python and C/C++, with experience of infrastructure-as-code and at least one major cloud provider ...

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 ...

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 ...

sometimes ambiguous tasks Desirable skills: Guidance knowledge - You have knowledge or training in the relevant standards and guidance relevant for medical device software (e.g. IEC 62304, IEC 81001-5-1) AI fluent - You have strong technical knowledge of modern generative AI (e.g., LLMs, embeddings, RAG, fine-tuning ...

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 ...

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. ...

broader software team. Ensure software quality through code review, unit and integration testing, and strict adherence to CoMind’s software development lifecycle under IEC 62304. Collaborate with electronics and FPGA teams on hardware-software interfaces, supporting hardware bring-up, system integration, and complex debug. Contribute to risk management … embedded Linux environments, including device driver development and hardware abstraction Experience in a regulated industry (medical devices, aerospace, automotive, or similar) including familiarity with IEC 62304 or equivalent software development standards Strong understanding of hardware-software integration, including FPGA or microcontroller interfaces, communication buses (SPI, I2C, UART, PCIe ...

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 ...

software development, hardware-in-the-loop testing, device connectivity (USB, Wi-Fi, Bluetooth), and video streaming or imaging devices. Familiarity with medical device standards (IEC 62304) and safety-critical testing is a strong plus. Physical Job RequirementsThe above statements are intended to describe the general nature and level ...

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 engineering. Safety assessment, hazard analysis, independent review or assurance cases. Static analysis, formal methods, model checking, verification or validation. Standards such as IEC 61508, ISO 26262, DO-178C, EN 50128, IEC 62304 or related frameworks. Regulated sectors such as nuclear, defence, rail, aerospace, medical devices, automotive ...

teams Nice to Have Experience with AI/ML-based medical devices Background in primary care or general practice Familiarity with ISO 13485 or IEC 62304 Experience with EU MDR compliance Equity: Meaningful equity stake in a growing company Private health insurance 25 days holiday + bank holidays ...

compliance with current GCP, FDA 21 CFR Part 11, EU Annex 11, GAMP, FDA QSR Part 820 (QMSR), EU MDR (Regulation 2017/745), IEC 62304, GDPR, ISO 13485, ISO 27001 and ISO 42001/EN 18286 regulatory & management system requirements. Essential Duties and Responsibilities: Act a subject ...

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 ...

Notified Body audits, with a focus on Design and Development aspects. Champion compliance in software development by translating complex and opaque IEC/ISO standards into clear, actionable processes that engineering teams can follow. What we will look for SaMD Experience : Prior experience working on Software as a Medical … Device (SaMD) or other regulated healthtech products, ideally in a start-up or scale-up environment. Standards: Strong working knowledge of standards such as IEC 62304, ISO 14971, and ISO 27001, and the ability to apply these in practical, developer-friendly ways. Technical Skills: A solid understanding ...

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 ...

Reporting to Legal & Regulatory Affairs and collaborating with Engineering, you’ll ensure medical software meets global device standards. You will drive design control per IEC 62304, ISO 14971 and ISO 13485, translating complex rules into practical processes for engineers and product teams, and supporting audits and regulatory submissions. ...