STM32). Familiarity with RTOS, bare-metal, or embedded Linux environments. Professional experience utilising Docker containers. Experience with communication protocols (UART, SPI, I2C, USB). Experience with IEC 62304, ISO13485, or FDA 21 CFR Part 820. Strong understanding of software development lifecycle and version control (e.g., Git). Qualifications Bachelor's or Master's degree in computer More ❯
work as part of a multi-disciplinary team DESIRABLE REQUIREMENTS: Use of schematic capture software Circuit analysis experience Knowledge of simulation packages Mathematical analysis skills Experience working within an ISO13485 or similar quality system Experience following IEC 62304 or similar Development of test harnesses and tools using C#/.NET. More ❯
tools and environment. Suggests changes to current Optos systems to improve efficiency and quality of software development. All activities to be carried out in compliance with the Optos SDLC, ISO13485 and FDA Medical Device Design Control processes. MINIMUM QUALIFICATIONS Educated to degree level in a software engineering discipline or equivalent education gained through work experience. 5+ years' experience in designing More ❯
team. Own the codebase – Drive full lifecycle development of embedded software (C/C++, RTOS, bare-metal systems). Set the standards – Ensure compliance with industry regulations (IEC 62304, ISO13485, etc.). Collaborate globally – Work alongside electronics, systems, quality, and R&D teams to deliver world-class products. Innovate and evolve – Promote best practices, continuous improvement, and More ❯
embedded software team.Own the codebase - Drive full lifecycle development of embedded software (C/C++, RTOS, bare-metal systems).Set the standards - Ensure compliance with industry regulations (IEC 62304, ISO13485, etc.).Collaborate globally - Work alongside electronics, systems, quality, and R&D teams to deliver world-class products.Innovate and evolve - Promote best practices, continuous improvement, and cutting-edge More ❯
subsystem architects and external partners, while managing technical debt and prioritizing customer-centric non-functional requirements. Ensure software compliance with medical regulatory standards like FDA, MDR, IEC 62304 and ISO 13485.Maintain comprehensive documentation to support regulatory submissions, audits, and compliance reviews. Collaborate with global R&D teams and stakeholders in marketing, PMO, quality, regulatory, and service functions.Serve as a … teams in multiple product launches. Your skills include a strong background in clinical applications, systems integration, interoperability, and knowledge of medical device regulations like IEC 62304, FDA, MDR, and ISO 13485.You are familiar to work in agile development methodologies like SAFe, apply AI/ML technologies, and are able to solve problems using modern C++ code. You have a More ❯
City of London, London, United Kingdom Hybrid / WFH Options
Oho Group Ltd
level driver development. Strong understanding of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO13485, FDA guidelines) is highly preferred. More ❯
Cambridgeshire, England, United Kingdom Hybrid / WFH Options
Oho Group Ltd
level driver development. Strong understanding of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO13485, FDA guidelines) is highly preferred. More ❯
level driver development. Strong understanding of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO13485, FDA guidelines) is highly preferred. More ❯
cryptographically protected communication channels Knowledge about implementation of BLE systems for secure and robust communications Experience developing embedded systems for early-stage medical devices under IEC 60601, 62304, and ISO13485 Notice By submitting your application, you acknowledge that Motif Neurotech will process your personal data for recruitment purposes. This includes evaluating your qualifications, contacting you regarding the More ❯
Manufacturers. Your responsibilities: Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit processes Be involved in maintaining … equivalent Work experience - Minimum of four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO13485, EU MDR, ISO 14971, etc. … demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable skills: Work experience - Experience working with ISO 27001 Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information Ferociously curious - You like going down rabbit holes, understanding More ❯
Engineer. In this role you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for the maintenance of the quality system to ISO13485 standards and associated product certification. As a Quality Systems Engineer, you will: Support the maintenance and continuous improvement of our ISO13485 compliant Quality Management … audits. Analyse quality data and contribute to process improvement initiatives. Required experience: 2+ years of experience in a Quality role within the medical device industry Hands-on knowledge of ISO13485 and 21 CFR 820 Strong attention to detail and problem solving skills Ability to work as part of a multi-disciplinary, fast-paced diverse team Ability to More ❯
lead Computer Systems Validation across the site and support the execution of the Validation Master Plan. You will ensure compliance with regulatory requirements (21 CFR Parts 11, 211, 600, ISO 9001, ISO13485) and provide guidance on validation issues. Your responsibilities will include participating in investigations for failures, managing CAPA, and driving continuous improvement initiatives while maintaining More ❯
Electronic Medical Records (EMR)solution called Clinicalvision, designed specifically for the renal market and the management of clinical records for CKD, ESRD and transplant patients. Clinical Computing is an ISO13485 Medical Device certified organisation. Clinical Computing along with Mediqal H.I., its sister company in the UK, are both members of the Constellation Kidney Group. Key Responsibilities Create … also be familiar with help desk software. Ultimately, you will help maintain our reputation as a company that offers excellent customer support. Responsibilities Undertake activities in accordance with our ISO13485 Medical Device Quality Management System. Diagnose and troubleshoot technical issues. Ask customers targeted questions to quickly understand the root of the problem. Track computer system issues through More ❯
or related field (or equivalent work experience). Previous experience in a fast-paced PCB fabrication environment required. Familiarity with quality systems such as ISO 9001, AS9100 or ISO13485 is a plus. If you are passionate about leading teams in a dynamic environment and possess the necessary skills, we encourage you to apply for this exciting opportunity as a More ❯
on integration needs. Familiarity with integrating automated liquid handling solutions Participation in product development and experience with verification and validation activities for automation workflows; familiarity with regulated environments (e.g., ISO13485, IVD, CLIA) is helpful but not required. Strong collaboration and communication skills, with the ability to work in fast-paced, cross-functional environments. Comfortable reprioritizing project work More ❯
product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers’ technical support activities. Hands-on More ❯
product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers’ technical support activities. Hands-on More ❯
procedures, identify instrument/component performance, ensuring all observations and data are recorded. Analysing results and experimental data to determine pass/fail. All activity to comply to ISO9001 & ISO13485 (cGMP) Responsible to the Maldi Test Manager for: Final test of MALDI TOF instrument systems, checking their performance for reliability and specification levels under a various conditions. … team measures, facilitating and driving continuous improvements. When required, train new engineers and peers. Correct use of tools and processes, described in SAMI's & Test procedures. Comply to ISO9001 & ISO13485 (cGMP) If required Commissioning of instruments within the U.K. and R.O.W. territories Qualifications (E/D): Degree/HND science/engineering basis; Chemistry, Physics, Biological, Electronics More ❯
Out: ? Real ownership of Quality & HSE systems ? Influence group-wide safety and compliance initiatives ? Collaborative, high-performing team ? Exceptional benefits and career development ?? Key Responsibilities: Accreditation & Compliance Maintain ISO9001, ISO13485, ISO18001, ISO14001, and ISO45001 standards Conduct internal and external audits Ensure REACH and ROHS compliance Manage CAPA and document control systems Quality Control Improve manufacturing quality controls to reduce defects … Were looking for someone with: Proven track record in a quality management role within electronics manufacturing or a similarly regulated industry Strong working knowledge of ISO standards (ISO9001, ISO13485, ISO14001, ISO45001) Proven experience in QMS development , Lean , and Continuous Improvement (CI) methodologies Familiarity with embedded systems , cables , touch screens , or electronic engineering Experience managing supplier quality , customer returns , and More ❯
and strategically 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 … environment, ensuring 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. … translating 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 More ❯
Eynsham, England, United Kingdom Hybrid / WFH Options
Scientis Search Ltd
Comfortable working in a small, fast-paced, and collaborative environment. Proficiency in project management tools (e.g., MS Project, Jira, Confluence, or equivalent). Familiarity with regulated environments (such as ISO13485) is a plus. Desirable Experience in optical systems, ophthalmic devices, or AR/VR hardware. Project management certification (e.g., PMP, Prince2, Agile/Scrum). Experience balancing More ❯
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 ISO13485 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, respiration) Exposure to More ❯
Bristol, Avon, South West, United Kingdom Hybrid / WFH Options
ADLIB Recruitment
SQL Experience working with data lakes, warehouses, and large-scale datasets Understanding of data privacy and security principles Exposure to life sciences, genomics, or regulated medical environments (such as ISO13485) or significant work within this sector/environment Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts More ❯
team of engineers across multiple disciplines (mechanical, electrical, software, systems) Oversee the design, development, testing, and validation of innovative medical devices in accordance with regulatory standards (e.g. FDA, CE, ISO13485) Drive project execution, ensuring timely delivery, budget adherence, and product quality. Collaborate cross-functionally with R&D, Quality, Regulatory, and Project teams to align engineering efforts with More ❯
