15 of 15 Remote/Hybrid IEC 62304 Jobs in England

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

work-from-home day. You will own CI/CD strategy, embedded Linux Yocto builds, V&V, and compliance-as-code workflows mapped to IEC 62304 and ISO 14971, while guiding data #J-18808-Ljbffr ...

that evidence automatically Own comprehensive test plans, protocols and execution reports for medical device software Drive formal software verification and validation in accordance with IEC 62304 (Class C) and ISO 14971 Advance test automation, CI/CD pipelines and new testing techniques, including LLM-assisted quality gates Work ...

device hardware, managing latency, memory and throughput within the CoMind One system. Medical Device Software Development: Design and develop medical device software to IEC 62304 and ISO 14971, from real‐time on‐device behaviour through to the interfaces clinicians touch. Compliance & Cybersecurity: Ensure AI deployments meet cybersecurity requirements ...

This role focuses on building verification workflows, test plans, and automated evidence generation to satisfy safety standards. You will drive software verification according to IEC 62304 and ISO 14971, advance CI/CD and test automation, and collaborate with systems engineers testing on real hardware. The position includes ...

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 ...