9 of 9 ISO 13485 Jobs in Cambridge

systems. Lead firmware architecture, requirements definition, and design from early concept through product release. Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971. Act as the firmware compliance leader, guiding the team … experience developing firmware for regulated medical devices, with products that have reached clinical, commercial, or regulatory submission stages. Demonstrated experience working within an ISO 13485–certified Quality Management System. Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied ...

technical consultancy environment, with direct responsibility for client relationships and expectations. Strong understanding of the product development lifecycle in a regulated environment ideally ISO 13485, from early concept and requirements to verification, validation, regulatory submission and transition to manufacture. Confidence working with technical specialists from different disciplines, with … minimum 2.1 in a degree or equivalent professional experience in engineering, physical sciences, product design or another relevant technical discipline. Working knowledge of ISO 13485 or comparable product-development quality frameworks Familiarity with medical device risk management, ideally ISO 14971. Experience managing medical software development projects, ideally ...

organisation. Present security risks and recommendations to senior leadership. Essential Experience 5+ years' experience in Information Security, Cybersecurity or Product Security. Strong experience with ISO 27001 and recognised frameworks such as NIST and OWASP. Experience conducting risk assessments, threat modelling and vulnerability management. Experience integrating security into software development … deliver pragmatic, risk-based solutions. Highly Desirable Medical Devices, HealthTech or Software as a Medical Device (SaMD). Product Cybersecurity experience. Knowledge of ISO 13485, ISO 14971, GDPR, HIPAA and FDA cybersecurity guidance. Experience with connected devices, mobile applications or cloud-hosted healthcare platforms. Qualifications Professional certifications ...

electronics, you can demonstrate significant industry experience in electronic hardware design including prototyping, ECAD, test and manufacturing. Project experience with medical device regulations (ISO13485). Other highly-regulated industry experience may be considered. Experience with FPGAs or Python for test automation would be desirable. Exposure to optics, embedded software ...

Docker, Kubernetes Experience with medical imaging data e.g. CT or MRI in DICOM format or clinical trial data Experience working in regulated, GxP or ISO 13485 environments Experience in respiratory or interstitial lung disease trials What can you expect from us A comprehensive benefits package that includesan annual ...

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 ...

hardware design, prototyping and ECAD work in a collaborative MedTech setting. Using Altium Designer, you will prototype, test and optimise architectures while complying with ISO13485 and related standards. Some travel may be required for international customer and supplier interactions. #J-18808-Ljbffr ...

Engineer to join their innovative medical devices team. The role involves developing safety-critical embedded firmware for insulin pump systems while ensuring compliance with ISO 13485 and other relevant standards. You will lead firmware architecture and work closely with cross-functional teams to establish best practices. The ideal ...

users. GxP-aware delivery. Deliver all technical support activities to a high standard, in line with Qureight SOPs and relevant regulations, including GxP requirements, ISO 27001 standards and data privacy regulations. To thrive in this role, you'll need: Previous experience in a technical support, application support, IT support … Zendesk or JIRA. Knowledge of Good Clinical Practice (GCP) with evidence of recent training. Experience working within a Quality Management System (QMS), e.g. ISO 9001, ISO 13485. Knowledge of relevant clinical trial regulatory, compliance and industry standards. Track record of working effectively and problem solving in a highly ...