capacity to develop: Firmware for application solutions (typically with ARM-based microcontrollers or ASIC cores) that complies with safety-related industry standards such as IEC62304 and ISO 26262. Test tools to verify correct behaviour of the application solutions and compliance to standards. Additional responsibilities can include development … development processes and quality standards is expected. Firmware for application solutions Develop firmware compliant with the following standards: ISO 9001:2015 - Quality management system IEC62304:2006 - Medical device software ISO 26262:2018 - Vehicle functional safety Collaboration with colleagues in Test and Applications Engineering, Hardware Design and Data … to software lifecycle quality processes in an ISO9001 framework. Working with at least one of the following standards: ISO 26262 - road vehicle functional safety. IEC62304 - medical device software. Not essential, but would be a strong advantage: Development of firmware specifically for sensing solutions or applications. Experience with more »
Bristol, Avon, South West, United Kingdom Hybrid / WFH Options
Elite People Partners Ltd
Due to the nature of my clients work any of the following Safety Software Development to standards would be of significant interest to them: IEC 61508, DO 178B/C, ISO26262, IEC62304 Role and Responsibility: To participate in RTOS product development, including, porting to different processor … environments. Working at processor level Cortex M3, M4, A7 Experience in a range of architectures, including ARM, MIPS, Power Safety Software Development to standards: IEC 61508, DO 178B/C, ISO26262, IEC 61508, IEC62304 Networking TCP, UDP Embedded software security Multicore devices Sector Experience of more »
Bristol, Avon, South West, United Kingdom Hybrid / WFH Options
Elite People Partners Ltd
Due to the nature of my clients work any of the following Safety Software Development to standards would be of significant interest to them: IEC 61508, DO 178B/C, ISO26262, IEC62304 Embedded Team Lead/Principal Engineer Role and Responsibility: The responsibility of this role … skills and experience are: Excellent understanding of software development within a DO178C development environment Safety Software Development to standards: DO 178B/C, ISO26262, IEC 61508, IEC62304 Low level embedded engineering experience i.e. working at processor level Cortex M3, M4, A7 Embedded software security Multicore devices more »
Job Responsibilities and Essential Duties Lead software validation and verification efforts to ensure compliance with FDA regulations and industry (e.g., 21 CFR Part 11, IEC62304, ISO 13485). Own the quality approval process for software components, including documentation review and final release approvals. Act as the SME … Previous experience supporting product software development and commercialization with a medical device company. Working knowledge of related QMS, regulations (e.g., 21 CFR Part 11, IEC62304, ISO 13485). Understanding of software development methodologies and concepts. Strong oral and written communication skills in English. Advanced proficiency in the more »
of quality into software development, scientific computation, and data acquisition functions. Ensure compliance with FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, and IEC62304 standards. Develop and maintain software quality assurance plans, including risk management and validation strategies, to ensure compliance with regulatory requirements. Collaborate with … 5+ years' experience in software quality engineering within the medical device industry. Required Knowledge, Skills and Abilities Strong understanding of FDA regulations, ISO 13485, IEC62304, and 21 CFR Part 11. Experience with risk management processes and tools, including FMEA and fault tree analysis. Proven ability to work more »
R&D sites (Netherlands, China, and India). • Lead the harmonization of test processes across multiple product lines, ensuring scalability, efficiency, and compliance with IEC62304, ISO 13485, and FDA 21 CFR Part 820. • Act as a senior advisor to leadership on test strategy, influencing investment decisions in … automotive, aerospace). • Expertise in enterprise-level test strategy development, with a proven track record of implementing large-scale automation frameworks. • Deep regulatory knowledge (IEC62304, ISO 13485, FDA regulations) and experience in embedding compliance into test processes. • Strong leadership, stakeholder management, and influencing skills, with experience engaging more »
with 5 years plus low level embedded C programming and knowledge of real time operating systems and ARM architectures. Expertise in Safety Software standards: IEC 61508, DO 178B/C, ISO 26262, IEC62304 would be very useful but not essential. Please send your CV to Emma.Windows more »
C/C++ for embedded systems Experience with real-time operating systems (VxWorks, SafeRTOS) Background in safety-critical industries , ideally medical devices Knowledge of IEC62304 and regulatory compliance is a plus This is an opportunity to be part of a company that is making a real impact more »
2016. Familiarity with relevant ISO standards: ISO 13485:2016 and/or FDA 21 CFR Part 820 and related guidance (desirable) ISO 14971 (desirable) IEC 60601-1/2 (beneficial) IEC62304 (beneficial) ISO 10993 (beneficial) ISO 62366 (beneficial) Awareness of the design control process for medical 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)
will be used to working to an ISO9001 framework and ideally you will also have experience with medical or automotive industry standards such as IEC62304 and ISO26262. Skills and experience you will need: A good engineering or scientific degree from a well-respected university Experience with developing more »
Peterborough, Cambridgeshire, UK Hybrid / WFH Options
NeoGenomics Laboratories
parallel computing (desired). Prior experience with work in a regulated environment, in particular for software and quality assurance, such as ISO 13485, EN 62304, ISO 15189, or other (desired). All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex 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 »
relevant regulatory standards. Role: Architect and develop robust software solutions to create an MVP meeting all SaMD requirements. Collaborate on design, ensuring adherence to IEC62304, ISO 13485, and ISO 14971. Manage CI/CD pipelines and integrate third-party software. You will bring: 5 years experience in … and cloud applications for medical devices. Proficiency in relevant programming languages (e.g., Python). Comprehensive knowledge of medical device standards, including experience with usability (IEC 62366) and security-related standards. Experience with DevOps and CI/CD practices. It would be advantageous if you have: Strong software testing skills. more »
Bedford, Bedfordshire, South East, United Kingdom Hybrid / WFH Options
Get Staffed Online Recruitment
Digital Product Manager Our client is recruiting for a Digital Product Manager (DPM) with a focus on Innovation to join their Marketing Department based at their Innovation Centre in Bedford, UK. This is an exciting opportunity that will enable you more »
Bedford, Cardington, Bedfordshire, United Kingdom Hybrid / WFH Options
Swiss Precision Diagnostics GmbH
Digital Product Manager We are recruiting for a Digital Product Manager (DPM) with a focus on Innovation to join our Marketing Department based at our Innovation Centre in Bedford, UK. This is an exciting opportunity that will enable you to 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 … goals 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 »