26 to 39 of 39 IEC 62304 Jobs

essential. If you're confident facilitating, coaching, and communicating across teams, you'll fit right in. You'll also need to be familiar with regulatory standards like ISO 13485, IEC 62304, and FDA's 21 CFR Part 820. Experience working on products that combine hardware and software is important, especially if you've delivered medical device software that … complies with IEC 62304. And finally, if you've had experience developing compliant processes and presenting project updates to executive leadership, that will help you stand out. You. Unlimited We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and More ❯

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 ❯

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 ❯

Software Engineering, Computer Science, Electrical Engineering Min 8 years' experience; proficiency in programming languages Linux OS, familiarity with test-driven development (TDD), CI/CD, and regulatory standards like IEC 62304 Experience in Class B and C medical devices preferred 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 ❯

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 ❯

communication skills and experience in creating alignment between broad varieties of stakeholders (internal and external Strong influential leadership skills Affinity to medical device standards and regulatory requirements (e. g. , IEC 62304) In-depth knowledge of SW development (including enterprise level SW) Experience in the fields of Cloud computing/networking/security (e. g. , CISSP, CISA) Experience in 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 ❯

minded RA/QA Senior Specialist with deep expertise in Software as a Medical Device (SaMD) and artificial intelligence (AI) regulatory frameworks, including the EU AI Act, ISO/IEC DIS 42001 (AI Management System), ISO/IEC 23894 (AI Risk Management), BS 30440:2023 (Validation framework for AI in healthcare), and MHRA guidance on Software and AI … alignment with evolving global standards and supporting innovation in regulated software development. Provide strategic oversight for interpreting and implementing regulatory frameworks such as the EU AI Act, ISO/IEC DIS 42001, ISO/IEC 23894, BS 30440:2023, ensuring comprehensive alignment with ethical, technical, and compliance considerations specific to AI and LLM applications in SaMD. Drive the … complex regulations into clear, strategic actions for cross-functional teams. Software Development Lifecycle: Provide strategic leadership over the software development and release management process, ensuring comprehensive compliance with ISO 62304 and ISO 13485. Collaborate closely with engineering leadership to ensure that software modifications and updates adhere rigorously to regulatory and quality expectations before approval and deployment. Lead and refine More ❯