1 to 25 of 56 IEC 62304 Jobs

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 (IEC 62304, 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 ❯

have been demonstrated/achieved. Minimum eight (8) years of experience in quality engineering in the FDA QSR/ISO 13485 medical device industry. Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), IEC 60601 (Medical Electric Equipment) and IEC 62366 Usability Engineering, required. Experience with Agile software development More ❯

aspects of acquired implantable medical devices. Support software architecture, development, testing strategies and risk management activities for software applications Evaluate compliance and ensure software/firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971and other regulatory standards governing medical devices. Contribute to defining test strategies (Unit/Integration) and draft design verification protocols to verify software … automated test environments. Identify potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies. Ensure acquired software meets medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance, IEC 62443. Collaborate with cross-functional teams, including hardware engineers, systems engineers, quality, regulatory affairs, manufacturing and PMO to ensure seamless device integration. Establish and document software development lifecycle (SDLC More ❯

Engineers to develop and implement robust and efficient testing strategies, supporting risk management efforts for all software applications. Evaluate compliance and ensure that software and firmware development align with IEC 62304, FDA, ISO 13485, ISO 14971, and other regulatory standards governing medical devices. Oversee the development of testing strategies (Unit/Integration) and Design Verification protocols to verify More ❯

of analog front-end design for sensor integration. Experience developing hardware and/or FW/SW for medical devices in compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 60601, IEC 62304) and DFM practices. Familiarity with Design Control processes, including requirements management, risk analysis (e.g., FMEA), and verification/validation testing. More ❯

quality (design assurance/controls) role in the medical device/IVD (or FDA regulated) industry. • Experience and working knowledge of applicable regulations and standards: FDA QSR, ISO 13485, IEC 62304, ISO 14971 • Expertise in SDLC best practices, and experience with industry tools such as Atlassian (Jira) and Jama. • Experience with Agile/Scrum/iterative software development More ❯

Engineers to develop and implement robust and efficient testing strategies, supporting risk management efforts for all software applications. Evaluate compliance and ensure that software and firmware development align with IEC 62304, FDA, ISO 13485, ISO 14971, and other regulatory standards governing medical devices. Oversee the development of testing strategies (Unit/Integration) and Design Verification protocols to verify 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 IEC 62304, 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 ❯

degree preferred. 5+ years of work experience as a FuSa engineer or related role focused on safety critical software Specific experience with ISO or similar functional safety standard (e.g., IEC 61508, IEC 62304, MIL-STD-882E) Specific experience with Software Development Processes such as ASPICE and coding standards (MISRA) Experience with safety analysis techniques such as Software More ❯

integrated development environment (IDE) tool Prior experience creating and executing software testing at unit, integration, and system levels Familiar with FDA/ISO regulations for software development, prefer including IEC 62304 Understanding of Software Development Lifecycle Management (SDLC) - (Agile/Scrum, iterative) Good interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a variety of More ❯

integrated development environment (IDE) tool Prior experience creating and executing software testing at unit, integration, and system levels Familiar with FDA/ISO regulations for software development, prefer including IEC 62304 Understanding of Software Development Lifecycle Management (SDLC) - (Agile/Scrum, iterative) Good interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a variety of 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 ❯

technology stack decisions (languages, frameworks, databases) appropriate for a high-performance, regulated medical device Integrate software development processes with medical device Quality Management System (QMS) requirements (e.g. ISO 13485, IEC 62304) Collaborate closely with Hardware, AI, Clinical, and Regulatory teams to ensure seamless system integration and alignment with product vision REQUIRED EXPERIENCE 5+ years of experience in software … Electrical Engineering, or a related technical field Proven experience designing, developing, and deploying software for medical devices, including deep understanding of medical device software lifecycle processes and standards (e.g., IEC 62304, ISO 13485, FDA 21 CFR Part 820) Hands-on experience developing and maintaining requirements traceability matrices (RTMs) to link system, software, and hardware requirements; creating and updating 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 (IEC 62304, 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 (IEC 62304, 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 IEC 62304, 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, IEC 62304, 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 ❯

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 IEC 62304 & 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. IEC 62304, 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 ❯

plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols, etc. Support integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes Ensure organizational compliance to the QMS system including ongoing training and education on software QMS and SDLC framework Provide CAPA, complaints, audit … in the FDA QSR/ISO 13485 medical device industry, primarily working on software integrated into advanced electromechanical systems i.e. robotics Experience with the application of relevant standards including IEC 62304, AAMI TIR45, ISO 14971 and IEC 62366 Demonstrated ability to implement and improve Software QMS processes using SDLC best practices, tools and agile/scrum/ More ❯

work you can expect to focus on the following: Ensures new product development activities and records are in accordance with regulations (such as ISO 13485, ISO 9001, ISO 14971, IEC 62304, IEC 82304, and 21 CFR 820) and company policies. Coach, mentor, teach, and influence colleagues in best quality practices and compliance with Proscia's quality management … processes and best practices for design control. Bachelor's degree or similar coursework in engineering, science, mathematics, or related technical field. Advanced knowledge of ISO 13485, ISO 14971, and IEC 62304, with practical application experience. Demonstrated ability to lead cross-functional quality initiatives, manage risk, and drive results in a lean, fast-paced environment. Familiarity with cybersecurity risk 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, IEC 62304) 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 ❯

processing Basic understanding of optics Experience in other programming languages such as Java Experience in medical device (FDA) or other regulated body standards and submissions Familiarity with ISO 60601, IEC 14971, IEC 62304, etc If you have a project that you've worked on that you're proud of, please, show it off! Let us know what More ❯

We are seeking an experienced Quality Engineer to manage creation of quality deliverables on a diagnostic instrument design project which includes software development and IEC 62304 compliance . This role ensures the integration of quality into both hardware and software design processes, maintaining compliance with regulatory standards such as ISO 13485 , FDA 21 CFR Part 820 , and IEC 62304 . The successful candidate will work cross-functionally to ensure the diagnostic system meets all applicable safety, performance, and regulatory requirements. Key Responsibilities: Lead and coordinate quality engineering deliverables for both hardware and software components of diagnostic instrument design projects. Ensure software development processes comply with IEC 62304 , including software risk classification, software requirements traceability … SRS) , Software Architecture , V&V Protocols , and associated quality documentation. Facilitate and participate in comprehensive risk management activities, including software-specific risk analysis in accordance with ISO 14971 and IEC 62304 . Maintain traceability matrices ensuring linkage between software requirements, design inputs/outputs, risk controls, and V&V activities. Ensure that software risk mitigations are properly documented More ❯

job poster from CDM Technology We are seeking an experienced Quality Engineer to manage creation of quality deliverables on a diagnostic instrument design project which includes software development and IEC 62304 compliance . This role ensures the integration of quality into both hardware and software design processes, maintaining compliance with regulatory standards such as ISO 13485 , FDA … CFR Part 820 , and IEC 62304 . The successful candidate will work cross-functionally to ensure the diagnostic system meets all applicable safety, performance, and regulatory requirements. Key Responsibilities: Lead and coordinate quality engineering deliverables for both hardware and software components of diagnostic instrument design projects. Ensure software development processes comply with IEC 62304 , including software … SRS) , Software Architecture , V&V Protocols , and associated quality documentation. Facilitate and participate in comprehensive risk management activities, including software-specific risk analysis in accordance with ISO 14971 and IEC 62304 . Maintain traceability matrices ensuring linkage between software requirements, design inputs/outputs, risk controls, and V&V activities. Ensure that software risk mitigations are properly documented More ❯

in an IVD environment along with practical experience in working to applicable management standards (i.e. ISO 13485). Experience with and demonstrable understanding of some of the following: IEC14971, IEC 62304, IEC 62366, GLP, EMC (IEC61326), IEC61010-1, packaging/transport standards, labelling standards and IVDR performance evaluation requirements Desirable: Experience of leading (from the manufacturer side More ❯

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., IEC 62304 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 ❯

degree in Science or Engineering is required; a postgraduate degree is preferred. Experience Minimum of 5 years of related work experience in hardware engineering; experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred Leadership Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader within More ❯