19 of 19 ISO 13485 Jobs in England

someone who enjoys systems thinking , understands how to balance regulatory compliance with delivery pace , and can act as a technical authority across IEC 62304, ISO 13485, and risk-driven development . You’ll be influential in shaping process, architecture, and engineering culture , while remaining close to the technical … detail. Key Responsibilities Own and evolve software lifecycle processes aligned to IEC 62304 and ISO 13485 Lead system-level requirements, architecture, and risk management activities Ensure compliance with ISO 14971 (beneficial standard) risk management and medical device regulations Act as a technical interface between software, systems ...

within the medical device or regulated environment. Demonstrated success in software validation and verification, ideally with exposure to medical device standards (e.g., IEC 62304, ISO 13485). Strong organizational and project management skills. Key Competencies Expertise in developing and implementing robotic manipulation algorithms (e.g., motion planning, control, perception … C++, Python, or related languages for robotic software development. Strong grasp of software validation methodologies, automated testing, and quality assurance processes. Knowledge of ISO 13485, MDD/IVDD, IEC 60601x, ISO 14971, and risk management documentation is a plus. Communication Excellent communication skills are essential ...

transition into medical technology Medical device or regulated industry specialists Embedded software engineers with experience in medical devices or other regulated environments such as ISO 13485, IEC 62304, aerospace, automotive safety, or similar sectors Package & Benefits £60,000 - £70,000 base salary (DOE) Generous employer pension contribution … consider applicants from three backgrounds: Medical device specialists, experienced embedded software engineers with a background in medical, healthcare, or other regulated environments such as ISO 13485, IEC 62304, aerospace, automotive safety, and similar sectors Regulated industry engineers, with transferrable skills from other safety critical or regulated sectors ...

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 Essential: Bachelors degree in 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 ...

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 Essential: Bachelors degree in 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 ...

France and for worldwide travel to visit subsidiaries/suppliers as required. Skills and Experience Required for the Quality Assurance Manager: Have experience with ISO13485 and medical device regulations (MDD & MDR) Ideally have completed Responsible Person Training based on the requirements on the Cogent Gold Standard. Have a life science ...

South and one in the Midlands to ensure full coverage of the UK Ensure full company compliance with the quality standard ISO 13485-2016 and security standard ISO 27001, Health and Safety and other regulated areas of the business The Ideal Person for the Clinical Applications Specialist ...

collaboration within a regulated medical software environment. What You'll Do Lead architecture and development of a high-performance iOS app. Work within ISO 13485/IEC 62304 processes and support product validation. Mentor developers and raise engineering standards. Collaborate with AI/ML, backend, product, and design ...

following would be a 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 ...

industries Degree and 8+ years of commercial experience Desirable Experience Experience working in a consultancy or project-based environment Compliance standards (e.g., IEC 62304, ISO 13485) Background in the medical, pharmaceutical, or healthcare industries Please note we cannot provide sponsorship for this role. If you are interested ...

industries Degree and 8+ years of commercial experience Desirable Experience Experience working in a consultancy or project-based environment Compliance standards (e.g., IEC 62304, ISO 13485) Background in the medical, pharmaceutical, or healthcare industries Please note we cannot provide sponsorship for this role. If you are interested ...

development Collaborate with external vendors/suppliers Support documentation required for testing You will bring the following Hands on software engineering within a ISO13485 environment Experience in full stack development across Azure Previous background in web and and cloud technologies BSc or MSc in a relevant Life Sciences subject ...

architect strategies Line management of a small team You will bring the following Hands on software engineering within medical devices with standard experience win ISO13485 and IEC62304 Prior experience as an Architect Full stack experience with IoT, cloud, web for both frontend and backend Previous track record of working across ...

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 ...

Linux system administration and networking concepts would be useful Any experience of working within a regulated setting and working to one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person ...

transition into medical technology Medical device or regulated industry specialists Embedded software engineers with experience in medical devices or other regulated environments such as ISO 13485, IEC 62304, aerospace, automotive safety, or similar sectors Package & Benefits £60,000 – £70,000 base salary (DOE) Generous employer pension contribution ...

programming and any one of the following: Embedded Linux e.g. Yocto or Buildroot build system Python Android build system Networking and communication protocols ISO13485/IEC61508 The ideal candidate will also have some familiarity with: Embedded OS use Power optimisation Makefiles/build configuration systems Basic soldering Unit testing ...

programming and any one of the following: Embedded Linux e.g. Yocto or Buildroot build system Python Android build system Networking and communication protocols ISO13485/IEC61508 The ideal candidate will also have some familiarity with: Embedded OS use Power optimisation Makefiles/build configuration systems Basic soldering Unit testing ...

validation and quality assurance activities. Working closely with the Validation Manager, you will ensure that systems-including SAP-meet the highest standards of GDP, ISO, FDA, and EU annexe 11 compliance. Your Tasks Will Include: Leading and supporting Computer System Validation (CSV) activities, including planning, executing, and documenting validation … other enterprise systems, electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence in audits, inspections ...