Livingston, West Lothian, United Kingdom Hybrid / WFH Options
Plexus Malaysia Sdn Bhd
testing experience Linux, RTOS, and bare-metal programming Hardware/software integration and debugging Full life cycle product/software development Agile/Scrum experience Experience in regulated industries (IEC62304, DO-178) ADDITIONAL DUTIES Assist with project estimation and planning Participate in continuous improvement Occasional travel may be required (estimated Why you will love it? At Plexus More ❯
and the Regulatory team, to develop safe and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC62304, ISO 14971, IEC 62366, IEC 13485, and FDA regulations, including cybersecurity requirements Implementation & Compliance: Develop software solutions and support cross-functional development activities, ensuring adherence More ❯
tools (e.g. Jira, Git). Experience with code quality/reliability standards (e.g. MISRA). Desirable Qualifications: Experience working under a QMS and developing software for medical devices under IEC 62304. Experience in creating and maintaining a software system that enables effective setup of experiments, captures experimental data, and allows review and analysis of the experimental data. Experience in More ❯
develop, and maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough … Proficiency in Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity to join a fast-growing MedTech company at the More ❯
Basingstoke, Hampshire, South East, United Kingdom Hybrid / WFH Options
CURE TALENT LIMITED
develop, and maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough … Proficiency in Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity to join a fast-growing MedTech company at the 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 (IEC62304, ISO 13485, etc.). Collaborate globally – Work alongside electronics, systems, quality, and R&D teams to deliver world-class products. Innovate and evolve – Promote best practices, continuous More ❯
software team. Own the codebase - Drive full life cycle development of Embedded software (C/C++, RTOS, bare-metal systems). Set the standards - Ensure compliance with industry regulations (IEC62304, ISO 13485, etc.). Collaborate globally - Work alongside electronics, systems, quality, and R&D teams to deliver world-class products. Innovate and evolve - Promote best practices, continuous More ❯
desktop application development. The ideal candidate is a hands-on technical leader with experience in system-level design, cloud computing, and cybersecurity, particularly within FDA-regulated medical device software (IEC62304, cybersecurity compliance). Key Responsibilities: System Architecture & Technical Leadership: Design, develop, and optimize scalable, secure, and compliant software solutions for medical devices and connected health applications. Ensure … adherence to IEC62304, FDA, and cybersecurity regulations, addressing threat modeling, secure coding practices, and risk management. Work with cross-functional teams to architect cloud solutions, ensuring performance, scalability, security, and compliance. Implement cloud-native architecture, microservices, and containerization (Docker, Kubernetes). Deploy and manage Azure Cloud applications, ensuring reliability and efficiency. Implement DevOps practices, cloud storage solutions … intuitive and visually appealing user interfaces. Integrate mobile apps with cloud services and APIs, ensuring seamless data flow. Cybersecurity & Compliance Ensure secure software development practices in compliance with FDA, IEC62304, and ISO 27001. Implement identity management, authentication, and data encryption strategies. Conduct threat modeling, vulnerability assessments, and penetration testing. Address cybersecurity challenges in connected medical devices and More ❯
science-based engineering practices during design reviews, decision-making, problem solving, and verification testing, emphasizing risk management and safety. Regulatory Compliance: Ensure adherence to relevant medical device standards (e.g., IEC 60601-1, IEC 60601-2-xx, IEC62304) and quality procedures for regulatory approvals. Cross-functional Collaboration: Foster strong relationships across R&D, PMO, product management … You are experienced with embedded electronic/software systems, including communication technologies like TCP/IP, Ethernet, USB, WiFi, Bluetooth, software design, object-oriented programming, APIs, software quality, and IEC 62304. You have worked within an ISO 14971 quality system, including experience with product approvals for EU-MDD, EU-MDR, and FDA. You demonstrate flexibility, adaptability, and a willingness More ❯
Experience with cybersecurity and 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 ISO 13485 Notice By submitting your application, you acknowledge that Motif Neurotech will process your personal data for recruitment purposes. This includes evaluating your qualifications … exempt, salaried US employees Please click here to apply. Tagged as: ARM Cortex-M medical device job , BLE firmware developer medical , embedded firmware engineer healthcare , embedded systems engineer London , IEC62304 embedded systems , Motif Neurotech careers , neural interface systems engineer , neurotech firmware jobs UK , regulated embedded systems jobs UK , wireless brain stimulator engineer More ❯
Nottingham, Nottinghamshire, East Midlands, United Kingdom
ETS Technical Selection
GTK, and CMake. Experience in designing and implementing graphical user interfaces. Competence in writing well-tested and testable code. Understanding of software development in regulated industries, especially medical (e.g., IEC62304 compliance). Strong communication skills, with the ability to explain technical concepts to non-technical stakeholders. Capable of working independently, prioritising tasks, and meeting project deadlines. Willingness More ❯
management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC62304, 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 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/IEC62304 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 ❯
Manchester, North West, United Kingdom Hybrid / WFH Options
Genedrive
in Manchester, focused on developing innovative molecular diagnostic solutions that improve patient outcomes worldwide. Certified to ISO 13485:2016 and operating in compliance with BS EN ISO 14971 and IEC62304, Genedrive is dedicated to meeting the highest standards in medical technology. With a strong collaborative culture and a mission to make diagnostics more accessible and efficient, Genedrive … and ISO 14971 Experience with internal/external audits and training delivery Excellent analytical, organisational, and communication skills Comfortable working independently and within cross-functional teams Desirable: Knowledge of IEC62304, ISO 60601, and global radio regulations Experience with global medical device regulations particularly UK, EU and USA Familiarity with the commercialisation of IVD products ISO More ❯
and maintain robust Python applications for medical device software Collaborate with cross-functional teams, including R&D, product management, and QA Ensure software meets regulatory standards (e.g., ISO 13485, IEC62304) for medical devices Write clean, efficient, and well-documented code following best practices Participate in code reviews, testing, and continuous improvement initiatives Requirements: Strong experience in Python 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 IEC62304 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 ❯
external information security assessments. Qualifications Essential 5+ Years experience in QA/RA within a regulated medical device environment ISO 13485, QMS/ISMS implementation and oversight, ISO 14971, IEC62304 Internal and external auditing experience Familiarity with EU MDR, US 21 CFR Part 820 Strong communication skills with the flexibility to engage effectively with diverse audiences System … cause analysis, risk assessment, documentation, project leadership, software development familiarity Strategic thinker, self-starter, cross-functional collaborator, efficiency-driven, pragmatic Preferred Experience hosting audits and managing CAPAs ISO 27001, IEC 62366, MDSAP Certified ISO 13485 internal auditor or lead auditor Broader global regulatory experience A confident and approachable communicator who can effectively challenge ideas while driving progress Training others More ❯
external information security assessments. Qualifications Essential 5+ Years experience in QA/RA within a regulated medical device environment ISO 13485, QMS/ISMS implementation and oversight, ISO 14971, IEC62304 Internal and external auditing experience Familiarity with EU MDR, US 21 CFR Part 820 Strong communication skills with the flexibility to engage effectively with diverse audiences System … cause analysis, risk assessment, documentation, project leadership, software development familiarity Strategic thinker, self-starter, cross-functional collaborator, efficiency-driven, pragmatic Preferred Experience hosting audits and managing CAPAs ISO 27001, IEC 62366, MDSAP Certified ISO 13485 internal auditor or lead auditor Broader global regulatory experience A confident and approachable communicator who can effectively challenge ideas while driving progress Training others More ❯