12 of 12 IEC 62304 Jobs in England

verify embedded software and tools for Class III Active Implantable Medical Devices. Lead subsystem and component design, ensuring robust integration and compliance with IEC 62304. Produce and review software requirements, architecture, and detailed design documentation. Develop, qualify, and maintain manufacturing and test fixtures, including subcontractor tools. Apply electronic schematics … cybersecurity principles applicable to medical software. Familiarity with cloud computing or containerisation (Docker, AWS, Azure) for test and data systems. Strong working knowledge of IEC 62304 (software lifecycle), ISO 13485 (QMS), and ISO 14971 (risk management). Experience working with Notified Bodies, FDA, or MHRA on software-related ...

with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This is an opportunity ...

with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This is an opportunity ...

with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This is an opportunity ...

documentation, and cross-functional collaboration skills. Strong root-cause analysis skills across electro-mechanical and instrument systems. Experience applying standards such as ISO 13485, IEC 62304, 21 CFR 820, IVDR, IEC 62366. Familiarity with ISO 14971 risk management (FMEA, FTA etc.). Broad engineering understanding (mechanical systems ...

. 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 ...

test automation tools. Familiarity with CI/CD platforms and version control tools. Amazing to have: Experience with medical or safety-critical standards like IEC 62304. Knowledge of Git, Jira, Confluence, CppUTest, GTest, and Doxygen. Comfort working across software and hardware layers. Consultancy experience is a bonus. Please drop ...

software developmentpreferably 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 … 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, as you will collaborate closely with multidisciplinary teams ...

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 and the appetite ...

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 teams. Drive improvements ...

Security tooling: Snyk, SonarQube, OWASP ZAP, Burp Suite, Kali Linux Pen testing coordination and vulnerability management Terraform, Ansible, Docker ELK stack/SIEM Compliance: IEC 62304, ISO 27001, HIPAA, MDR Strong networking: VPCs, security groups, NACLs, load balancers Behaviours required: Takes ownership: full accountability for infra, tooling ...

Security tooling: Snyk, SonarQube, OWASP ZAP, Burp Suite, Kali Linux Pen testing coordination and vulnerability management Terraform, Ansible, Docker ELK stack/SIEM Compliance: IEC 62304, ISO 27001, HIPAA, MDR Strong networking: VPCs, security groups, NACLs, load balancers Behaviours required: Takes ownership: full accountability for infra, tooling ...