16 of 16 IEC 62304 Jobs in England

medical are sustaining work on legacy products. This isn’t. The team is small, newly formed, and defining everything now: architecture, firmware standards, IEC 62304 lifecycle, testing strategy, toolchain, and development processes. You get the rare combination of: A true greenfield mandate - set the architecture, coding standards, toolchain … algorithms teams behind you The device itself is demanding: closed‐loop sensing and actuation, dose‐critical safety logic, fault tolerance, multi‐year power budgets, IEC 60601, IEC 62304 Class C, and cybersecurity for connected delivery. If those constraints motivate you, you’ll thrive here. What ...

accordance with good software practices, with a preference for prior experience with standards and medical device regulations (e.g., ISO 13485, ISO 9001, ISO 14971, IEC 62304) Development of test plans and procedures, conducting and accurately documenting tests at the unit, sub-system, and system levels Collaborating with internal … suppliers Job Requirements: Experience in software development for medical devices or similar within an ISO regulated environment, working to associated regulations such as IEC 62304 Proficiency with source code management tools Familiarity with IEC 62304 compliant software development processes and standards to produce well-documented, maintainable ...

will be doing: Designing and developing embedded software for a Class II/III medical device Owning requirements, traceability, and DHF documentation to IEC 62304 and ISO 14971 standards Implementing and optimising RTOS based multi-tasking systems such as SafeRTOS Working with communication protocols including I2C, SPI, UART …/CD, Jira and UML tools Exposure to requirements management tools such as Codebeamer, Polarion or Jama A track record of delivering to IEC 62304 or an equivalent regulated framework Degree in Computer Science or a relevant engineering discipline Please apply if you are looking to have ...

science teams to ensure reliable communication, data transfer and system integration Generate and maintain software documentation, traceability, verification and validation activities in accordance with IEC 62304 Contribute to software architecture, development processes and testing approaches suitable for regulated medical device environments Experience and skills required Experience developing desktop … SDKs, software interfaces or integration layers for connected devices Proven experience working within medical devices or other regulated environments, with hands-on exposure to IEC 62304 Experience integrating software with BLE, wireless devices or other connected hardware systems Strong understanding of verification, validation, traceability and medical device software ...

science teams to ensure reliable communication, data transfer and system integration Generate and maintain software documentation, traceability, verification and validation activities in accordance with IEC 62304 Contribute to software architecture, development processes and testing approaches suitable for regulated medical device environments Experience and skills required Experience developing desktop … SDKs, software interfaces or integration layers for connected devices Proven experience working within medical devices or other regulated environments, with hands-on exposure to IEC 62304 Experience integrating software with BLE, wireless devices or other connected hardware systems Strong understanding of verification, validation, traceability and medical device software ...

Systems, ideally FreeRTOS or SAFERTOS • Low level embedded engineering experience - i.e. working at processor level - Cortex M3, M4, A7 • Safety Software Development to standards: IEC 61508, DO 178B/C, ISO26262, IEC 61508, IEC 62304 • Networking - TCP, UDP • Embedded software security • Multicore devices • MIPS and Power ...

services, infrastructure automation, and cloud security best practices. Background in medical imaging, life sciences, or other regulated software environments (e.g. ISO 13485, IEC 62304). Familiarity with DevOps pipelines, observability, and automated deployment at scale. Demonstrated ability to mentor junior engineers, lead code reviews, and shape architectural decisions. ...

directly to code-level activities (primarily C/embedded environments) Driving verification activities across the full software lifecycle Supporting certification to standards such as IEC 61508, DO-178C, ISO 26262 Mentoring engineers and setting best practices within the verification team Working closely with customers to provide technical guidance … environment Degree in Engineering, Computer Science, Maths or similar Strong communication skills and ability to engage with stakeholders Highly Desirable: Knowledge of safety standards ( IEC 61508, DO-178C, ISO 26262, IEC 62304 ) Experience with ARM architectures (Cortex M/A) or similar Understanding of debugging at processor ...

bonus: Skills in containerisation/orchestration (Docker, Kubernetes etc.); IaC; DynamoDB; Spring Boot and Gradle; knowledge of standards such as ISO 13485 or IEC 62304. This role is predominantly remote, with occasional attendance of the company's London office - you will therefore need to be based ...

accordance with good Software practise - Experience of relevant standards and medical device regulations would be beneficial (e.g. ISO 13485, ISO 9001 ISO 14971 and IEC 62304.) Development of test plans and procedures, conducting and accurately documenting the tests at unit, sub-system and system level. Working closely with internal … experience of software development for medical devices or similar within an ISO regulated environment and be able to work to associated regulations such as IEC 62304. Be able to work efficiently with source code management tools. Be familiar with IEC 62304 compliant software development processes and standards ...

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 ...

. Collaborate with V&V teams to support defect triage, issue resolution, and validation. Monitor regulatory changes and ensure compliance with standards such as IEC 60601 and ISO 14971. Conduct risk management activities including FMEA and hazard analysis. Champion continuous improvement across engineering tools and processes. Required Experience & Qualifications … biomedical, mechanical, electrical, or systems engineering (or equivalent). Strong background in high-reliability systems (e.g., ventilators). Deep understanding of ISO 14971 and IEC 60601-1 standards. Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release. Familiarity with ISO/IEC/IEEE ...

support QMS implementation. Key requirements: Proven experience with CE marked & FDA-authorised SaMD/AIaMD products Strong knowledge of ISO 13485, ISO 14971, IEC 62304/82304/62366 Confident leading submissions, client engagements, and multiple projects What's on offer: Possible extensions Flexible rate Remote working Please ...

engineers with a strong shipping record are equally valid Differential geometry, optimisation, or applied ML background Medical device software experience — MDR, FDA 510(k), IEC 62304 ...

improve clinical decision making and patient outcomes • Hybrid working with equity participation available through share options What They Are Looking For • Experience within IEC 62304 or other regulated software development environments • Strong Python capability with familiarity across C++ environments • Experience building scalable automated testing and release infrastructure • Experience ...

medical device and are looking to expand their engineering team. They are seeking an embedded software engineer with previous medical devices and medical standards (IEC62304) experience who will play a pivotal role in the engineering team. Key Skills and Experience Required: Embedded C programming STM32 Microcontrollers Medical device and medical … standards experience - IEC62304 ideally Degree qualified - Computer Science or similar In this role you will be responsible for the development of firmware and related software for the next and future generations of their devices, you will report directly to the Technical Director and can expect to work closely with other ...