1 to 20 of 20 Permanent IEC 62304 Jobs

Manage product verification and validation including creating and implementing test plans. Maintain an appropriate working knowledge of medical standards including but not limited to IEC 60601-1 Ed 3; ISO 14971; IEC 62366; ISO 62304; ISO 13485 & FDA guidelines CFR 21. Senior Hardware Design Engineer Position Requirements more »

devices. Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the medical device Industry. more »

experience in software architecture and Cloud & devops infrastructure (Azure) You have experience of GDPR and cybersecurity for connected applications. Knowledge of medical development standards (IEC 62304, ISO 14971, IEC 60601, IEC 62366) would be advantageous. You are Fluent in French and capable to have technical discussions more »

real time operating systems, ideally FreeRTOS and ARM architectures. It would be beneficial to have safety critical expertise with knowledge of Safety Software standards: IEC 61508, DO 178B/C, ISO26262, IEC 61508, IEC 62304 . I am seeking someone who wants a long term opportunity more »

HAVE” SKILLS AND EXPERIENCE : Experience of Functional Safety software development as per at least one of the Functional Safety standards: ISO 26262, EN 50128, IEC 61508, IEC 62304 Familiarity with the C and C++ Standard Libraries and C++14/17/20 language features Low-level programming more »

Provide technical guidance and mentorship to junior team members, fostering a collaborative and knowledge-sharing environment. Follow the medical device software development process (ISO 62304 compliance). Who we are looking for: You have a Master's or PhD degree in Computer Sciences, Software Engineering, Biomedical Engineering or similar more »

Azure Devops, Visual Studio Experience of design and validation of medical device software or other safety critical/regulated environments i.e. ISO 13485, EN 62304, 21 CFR 820, ISO 14971 compliance Curious and eager to learn with a growth mindset. This is a fantastic opportunity to work within a more »

ISO 14971: Knowledge of risk management principles in medical device development, enabling the identification, assessment, and mitigation of potential hazards to patient safety. ISO 62304: Proficiency in software lifecycle processes for medical device software, ensuring the development of safe and effective software that meets regulatory requirements. ‍ Join us in more »

Job Description Join a pioneering, well-funded company at the forefront of point-of-care diagnostics as a Mid or Senior Embedded Software Engineer. Their mission is to transform the management of infectious diseases with our cutting-edge technology, working more »

Experience with real-time data processing Experience with Python libraries such as, NumPy, Pandas, SciPy etc. Any Medical Device Software development and understanding of IEC 62304 would really set your application apart! What Next? If you're a Python focused Senior Software Engineer looking to work on a more »

ideally FreeRTOS, OPENRTOS® or SAFERTOS® Low level embedded engineering experience – ie 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 Salary and Benefits more »

have specific Aerospace expertise and knowledge of: DO-178C Experience with Software Development Frameworks (e.g. CMMI, ASPICE) Knowledge of Safety Software Development to standards: IEC 61508, ISO26262, IEC 62304, An awareness of cyber security standards: ISO 21434, ISO 27001 Experience with tools such as: DOORs, SVN, Azure more »

and maintenance. Manage the engineering budget to achieve product goals. Implement a robust software development process compliant with medical device regulations (ISO 13485, ISO-IEC 62304). Champion information security (ISO 27001) through design, penetration testing, and secure coding practices. Lead product management, managing backlog prioritization and stakeholder more »

desirable. Strong understanding of FDA regulations and regulatory submissions through 510k regulatory pathway. Strong understanding for SaMD development processes according to recognised standards (e.g., IEC 62304, IEC 82304), and other international regulatory requirements. Experience with managing Post-Market Surveillance activities for post-market surveillance reporting. Shortlisting for more »

Experience with real-time data processing Experience with Python libraries such as, NumPy, Pandas, SciPy etc. Any Medical Device Software development and understanding of IEC 62304 would really set your application apart! What Next? If you’re a Python focused Senior Software Engineer looking to work on a more »

Join a pioneering, well-funded company at the forefront of point-of-care diagnostics as a Mid or Senior Embedded Software Engineer. Their mission is to transform the management of infectious diseases with our cutting-edge technology, working alongside forward more »

years' experience in developing software and troubleshooting hardware issues * Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304 * Significant experience in formal software verification * Proficiency in C/C++ programming languages * Experience with Real-Time Operating Systems and bare-metal development * Demonstrated track record more »

cycle. Experience capturing product requirements, and planning and estimating software development work. Experience delivering medical electrical/electronic-based medical devices including knowledge of IEC62304 for medical software life cycle process Salary: circa £65k - £75k + benefits Vacancy Location: North Cambridgeshire (Commutable from Peterborough, Cambridge, Northampton, Bedford, St Neots, Stevenage more »

Job Description Join a pioneering, well-funded company at the forefront of point-of-care diagnostics as a Mid or Senior Embedded Software Engineer. Their mission is to transform the management of infectious diseases with our cutting-edge technology, working more »

Join a pioneering, well-funded company at the forefront of point-of-care diagnostics as a Mid or Senior Embedded Software Engineer. Their mission is to transform the management of infectious diseases with our cutting-edge technology, working alongside forward more »