11 of 11 Permanent IEC 62304 Jobs in England

pump systems Defining and improving firmware lifecycle processes, documentation, and audit readiness Working closely with Quality, Regulatory, and Systems Engineering teams Ensuring compliance with IEC 62304, ISO 13485, and medical device development standards Contributing to architecture, design reviews, risk management, and verification activities Mentoring engineers and supporting best … development Experience in regulated or safety‑critical domains (medical devices preferred but not essential) Strong understanding of structured development processes and documentation Familiarity with IEC 62304, ISO 13485, or similar compliance frameworks Ability to collaborate effectively with Quality & Regulatory teams A proactive mindset and confidence in leading technical ...

expansion. Key Responsibilities Lead the software development of medical devices from early-stage development through to commercial release Ensure software development activities comply with IEC 62304 and support regulatory submissions, including FDA 510(k) Coordinate multidisciplinary software teams, including software engineers, algorithm developers, UI developers, SDK developers … software architecture, technical decision-making, development and problem-solving Experience & Skills Required Proven experience leading software development for regulated medical devices Strong understanding of IEC 62304 and the medical device software development lifecycle Experience supporting FDA 510(k) submissions and commercial product releases Previous experience leading multidisciplinary software ...

principles An appreciation of electronics and hardware integration, beneficial rather than essential Familiarity with medical device standards and regulated pathways, for example ISO 13485, IEC 62304, ISO 14971, IEC 60601 and IEC 62366 Just as important as the person This is the part that will decide ...

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 ...

years of relevant development industry experience. Experience in an agile development environment is desirable. Desirable Attributes: Experience with clinical safety standards (DCB0129/0160, IEC 62304). Knowledge of the Healthcare Industry and NHS. Exposure to medical device software or diagnostic platforms. Unit testing framework experience (e.g., MSTest ...

relevant degree in Electronic Engineering or Software Engineering Experience working within a QMS environment, and/or exposure to regulatory standards such as ISO 62304 and ISO 60601 For more information or to apply, get in touch with KO2 Embedded Recruitment Solutions. ...

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 ...

OpenCV, Pandas, SciPy, NumPy, SciKit-learn, etc. Strong software engineering practices including version control, code review, software testing methodologies, and continuous integration; experience with IEC 62304 is particularly desirable Excellent oral and written communication skills, and comfort working at the interface between research, engineering, regulatory, and clinical teams ...

integrity, and a forward-thinking approach. You will act as the go-to subject-matter expert for all aspects of software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and AI-specific guidance such as ISO 42001. Your leadership will embed a culture … bodies. Design and execute Qureight’s digital biomarker validation strategy in the US and EU markets. Provide expert guidance on software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and ISO 42001, ensuring all systems and processes are compliant. Stay ahead of emerging ...

integrity, and a forward-thinking approach. You will act as the go-to subject-matter expert for all aspects of software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and AI-specific guidance such as ISO 42001. Your leadership will embed a culture … bodies. Design and execute Qureight’s digital biomarker validation strategy in the US and EU markets. Provide expert guidance on software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and ISO 42001, ensuring all systems and processes are compliant. Stay ahead of emerging ...

experience in Systems Engineering, Software Engineering, Digital Engineering, Computer Science or a related discipline. Desirable: Experience working with safety-critical software standards such as IEC 61508, Def Stan 00-055, DO-178 or IEC 62304. Security Clearance The successful candidate must be a sole UK National ...