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 … 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 More ❯
Hemel Hempstead, Hertfordshire, UK Hybrid / WFH Options
Zest Business Group
Quality professional with a strong track record in the Medical Devices sector, ensuring compliance with EU MDR & FDA QSR regulations. Expertise in ISO 13485, IEC62304, IEC 62366, and ISO 14971. Experience in high-growth/start-up environments, ideally within an international, remote-first engineering team. More ❯
Livingston, West Lothian, United Kingdom Hybrid / WFH Options
Plexus Malaysia Sdn Bhd
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 More ❯
engineering process maturity. Support recruitment, onboarding, and talent development within the team. Ensure all development aligns with relevant standards (e.g., ISO 26262, DO-178C, IEC62304, etc.). Key Requirements Proven experience as an Engineering Manager or Technical Leader in embedded/firmware software. Strong understanding of embedded More ❯
and Performing Verification Develop and execute verification plans, protocols, and reports. Ensure all system verification activities comply with regulatory standards (e.g., FDA, ISO 13485, IEC62304). Conduct risk analysis and ensure risk management activities are current and comprehensive. Developing Test Procedures Design and develop test cases and More ❯
Nottingham, Nottinghamshire, East Midlands, United Kingdom
ETS Technical Selection
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 More ❯
plus. Experience in project management of medical devices under Design Control (21 CFR Part 820) and ISO 14971, and developing to and compliance with IEC62304 is a plus. Demonstrated experience with Azure DevOps (ADO) as it applies to Agile software development is a plus. Experience coordinating team members in US More ❯
electronics and software development methodologies will be needed embedded systems with RTOS a plus. Youll ensure the project adheres to Regulations and Standards (ISO13485, IEC62304, FDA, CE Marking, etc) and Quality, and will keep abreast of Project Risks, Technical Documentation, and Project Tasks/Milestones. As well More ❯
Employment Type: Permanent
Salary: Healthcare, Pension scheme, LA, 25 days holiday (plus bank holidays)
with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards. Knowledge of ISO Standards including ISO 13485, ISO 9001, ISO 14971, IEC62304, and EN 60601. Knowledge of global regulatory requirements applicable to the company's products and services. Certification in Quality Management or Auditing More ❯
london, south east england, united kingdom Hybrid / WFH Options
CXC
in test automation (preferably Python and Kotlin) • Experience with virtualization, Linux, and remote device management. • Knowledge of medical device regulations and standards (ISO 13485, IEC62304, 21 CFR 820) Nice to Haves • BS/MS in Computer, Electrical, Electronics Engineering or equivalent industry experience • Advanced certification in software More ❯
software and electronics development methodologies, particularly in the medical device industry. Regulatory Compliance : Ensure all projects adhere to stringent regulatory standards (e.g., ISO 13485, IEC62304) and quality management systems. Project Risk Management : Identify, assess, and mitigate project risks, ensuring the safety and efficacy of our medical devices. More ❯
Have" Skills and Experience: Experience of Functional Safety software development as per at least one of the Functional Safety standards: ISO 26262, EN 50128, IEC 61508, IEC 62304. Experience developing compilers, ideally using frameworks such as LLVM/Clang, MLIR. Low-level programming in Arm Assembly. Presence and More ❯
customer needs with a strong focus on risk and safety. Contributing to the application of relevant medical device standards applied to EC products including IEC 60601-1, associated IEC 60601-2-xx particular standards and IEC 62304. Following quality procedures in line with engineering processes needed to … electronic/software systems (including communications technologies, such as TCP/IP, ethernet, USB, WiFi, Bluetooth), software design, object-orientated design, APIs, software quality, IEC 62304. You are knowledgeable on Linux, or have the capacity to develop this knowledge quickly. You have worked in product development within an ISO More ❯
quoting of new work, and resource management. Ideally, you will have a knowledge and experience of working on medical products in compliance with the IEC62304 and IEC60601 standards. To be successful in this position you will deliver exceptional leadership, communication and project management skills and a belief in developing the … Software team resource is assigned to projects Driving continuous improvement of best-in-class development procedures particularly focused on medical product development complying with IEC62304 and IEC60601 standards, and overseeing the successful integration of them into the business Working closely with the senior leadership team to identify and develop strategies … culture What We’re Looking For Essential Extensive experience of Electronics and Software product development, with at least some being in Medical (complying with IEC62304 and IEC60601 standards). Proven experience in an Electronics and/or Software leadership role. Experience of leading, developing and building teams. Strong commercial awareness. More ❯
The Ellison Institute of Technology (EIT) Oxford's purpose is to have a global impact by fundamentally reimagining the way science and technology translate into end-to-end solutions and delivering these solutions in programmes and platforms that respond to More ❯