26 to 35 of 35 IEC 62304 Jobs in the UK

transfer of the product from design to manufacturing, solving engineering issues in electronics, firmware, and production instrumentation Maintain, adapt, and optimise existing firmware within the constraints of regulatory compliance (IEC 62304, ISO 13485) Lead electronics design, schematic capture, and PCB layout using Altium Develop LabVIEW applications for test and instrumentation Collaborate with manufacturing partners to troubleshoot and resolve More ❯

work independently and prioritise tasks Excellent communication, interpersonal, organisational and IT skills Helpful experience: Experience with electronic Quality Management Systems (eQMS) Exposure to software as a medical device/IEC 62304 Technical/procedural writing experience Familiarity with medical device regulatory requirements in the UK, EU, or US Experience in an electronics-related medical device manufacturing environment would More ❯

anomaly detection) Proficient in Python and ML frameworks such as PyTorch or TensorFlow Familiarity with FDA regulatory pathways for medical software (e.g., 510(k), De Novo), and standards like IEC 62304 or ISO 13485 Experience with MLOps practices and model versioning in compliant environments Preferred Qualifications: Experience building ML models with wearable data (e.g., continuous heart rate, motion More ❯

defense, aerospace, etc.) is a plus. Experience in product development of medical devices under Design Control (21 CFR Part 820) and ISO 14971 and developing to and compliance with IEC62304 is a big plus. Experience in the development of integrated (hardware and software) devices. Experience with scripting languages (e.g., Bash, PowerShell). Experience with Containerized environments and virtual machines Experience More ❯

detection). Proficient in Python and ML frameworks such as PyTorch or TensorFlow. Familiarity with FDA regulatory pathways for medical software (e.g., 510(k), De Novo), and standards like IEC 62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Preferred Qualifications: Experience building ML models with wearable data (e.g., continuous heart rate, motion More ❯

hate them – you understand EPR systems and know how to use them (especially EPIC, Cerner, Altera). You find regulatory and safety frameworks fun (MDR, FDA, DTAC, ISO 62366, IEC 62304 etc). We love evidence and running evidence-generation studies – do you? Experience in usability engineering and human factors, including user research, risk analysis, evaluation, and documentation More ❯

defense, aerospace, etc.) is a plus. Experience in product development of medical devices under Design Control (21 CFR Part 820) and ISO 14971 and developing to and compliance with IEC62304 is a big plus. Experience in the development of integrated (hardware and software) devices. Experience with scripting languages (e.g., Bash, PowerShell). Experience with Containerized environments and virtual machines Experience More ❯

and human factors, including user research, risk analysis, evaluation, and documentation to support compliance, regulatory submissions, and post-market surveillance. You find regulatory and safety frameworks fun (ISO 62366, IEC 62304, EU MDR, FDA, MHRA). Why this role, Why now We’re at a defining moment - building core products, shaping regulatory pathways, and proving real-world value. More ❯

Publish-Subscribe pattern Experience of working with Jira, BitBucket and Git Experience in working within a regulated SDLC process (optional but advantageous) Experience in working in MedTech, including ISO 62304 (optional but advantageous) Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS More ❯

analytical and structured approach, and a great ability to work with people across the business. You'd be responsible for: Knowing the ISO standards applicable to us (13485, 14971, 62304, 82304 in particular) and understanding how they map onto day-to-day Flok activities and tools. Helping us design, implement, and improve processes for meeting the requirements. Working closely More ❯