5 of 5 ISO 13485 Jobs in the East of England

execute verification and validation strategies (including qualified tools and fixtures); and lead design transfer activities. Regulatory Compliance and QMS: Ensure supplier activities operate under ISO 13485 - compliant processes and deliver complete DHF/Technical Documentation regulatory expectations; align development to applicable standards. Risk, Submission and Audit Support: Lead … document risk management (ISO 14971), ensure readiness for UDI, labelling, post market surveillance, and change control, and support regulatory submissions and notified body audits by presenting clear technical rationales and objective evidence. Cross Functional and Stakeholder Integration: Integrate the electronics/software workstream with assay/chemistry, mechanical design ...

Engineer - Medical Devices: - Design, develop, and maintain embedded software in C for medical devices and safety‐critical systems. - Produce high‐integrity code compliant with ISO 13485 and associated medical standards. - Lead on software architecture, design reviews, and technical decision‐making. - Collaborate closely with hardware, systems, and quality teams … engineering within the medical device sector. - Strong proficiency in Embedded C and bare metal programming. - Hands‐on experience developing safety‐critical code aligned with ISO 13485. - Familiarity with structured development methodologies (e.g., V‐model, IEC 62304‐aligned processes). - Strong debugging, problem‐solving, and documentation skills. Desirable/Advantageous ...

Devices: - Design, develop, and maintain embedded software in C/C++ for medical devices and safety‐critical systems. - Produce high‐integrity code compliant with ISO 13485 and associated medical standards. - Lead on software architecture, design reviews, and technical decision‐making. - Collaborate closely with hardware, systems, and quality teams … engineering within the medical device sector. - Strong proficiency in Embedded C and bare metal programming. - Hands‐on experience developing safety‐critical code aligned with ISO 13485. - Familiarity with structured development methodologies (e.g., V‐model, IEC 62304‐aligned processes). - Strong debugging, problem‐solving, and documentation skills. Desirable/Advantageous ...

products - Lead the full hardware development lifecycle including requirements, design, prototyping, testing, debugging and production support - Ensure compliance with regulatory standards (e.g., IEC 60601, ISO 13485) - Conduct EMC testing and troubleshoot hardware issues - Collaborate with cross-functional teams to deliver integrated solutions - Maintain accurate documentation and stay current ...

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 a highly innovative ...