23 of 23 Permanent IEC 62304 Jobs

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 … 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 More ❯

Skills/Knowledge: Knowledge about applicable standards and regulations related with SW development for Health and/or Medical Device. (ISO 13485, ISO 14971, IEC 62304, IEC 82304, ISO 62366, cybersecurity) Familiar with medical device regulations (MDR/IVDR, FDA, etc) Skills & Capabilities: This position has a More ❯

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 More ❯

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, ISO 13485, and FDA regulations, including cybersecurity requirements. Implementation & Compliance: Develop software solutions and support cross-functional More ❯

software systems, and code refactoring) ? Experience with Linux and C/C++. ? Experience developing software for medical devices is required. ? Familiar with ISO 13485, IEC 60601-1 Clause 14, and IEC 62304 for software development is preferred. ? Knowledge of software version control/defect tracking tools required More ❯

Preferred: Master's degree in software engineering, computer science, electrical engineering or similar field. Direct Medical Device experience including working knowledge and application of IEC 62304, FDA Software Guidance, ISO 60601, ISO 13485 development processes and standards (or similar). Experience with automated testing of QT using tools More ❯

electrical schematics and system design Detailed understanding of principles and practice of Design Controls (CFR 820.30/ISO 13485), Medical Device Software Lifecycle (ISO 62304), and Risk Management (ISO 14971) Strong communication skills (both written and verbal) including the ability to influence without direct authority Strong device design and More ❯

agile software development , preferably using SAFe . A degree in Computer Science, Data Science, or a related field . Familiarity with medical device regulations (IEC 62304, FDA, MDR, ISO 13485). A commitment to delivering safe, effective, and ethical AI-driven healthcare solutions . Join us to drive More ❯

related activities. Relevant experience in risk management for medical devices. Good knowledge of Quality System standards and regulations including 21 CFR 820, ISO 13485, IEC 62304 and ISO 14971. Language - Business fluent (written and oral) in English is required Preferred: Master’s degree in engineering or life sciences More ❯

LDAP/NIS), authentication protocols (such as Okta, OAuth, OpenID, etc.) is desired. Experience with software development methodologies such as Agile, SDLC as per IEC62304 is desired. Experience with end-to-end DevOps (from requirements to implementation to production to operations) tools such as Azure DevOps, GitHub, etc. is desired. 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, IEC 62304). Conduct risk analysis and ensure risk management activities are current and comprehensive. Developing Test Procedures Design and develop test cases and More ❯

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 More ❯

degree in Computer Science, Information Technology, or a numerical, engineering or life science field. Strong understanding of data security and compliance requirements (HIPAA, GDPR, IEC 62304, etc.). Strong communication and interpersonal skills. Excellent problem-solving skills and the ability to troubleshoot complex issues. A job description does 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, IEC 62304, FDA, CE Marking, etc) and Quality, and will keep abreast of Project Risks, Technical Documentation, and Project Tasks/Milestones. As well More ❯

with medical device international regulations and related standards (ISO 13485, ISO 14971, ). Knowledge and experience working in Medical device software life cycle process (IEC 62304) Desirable: Knowledge and experience working in medical device regulatory submissions (MDR/IVDR,FDA ) Internal auditor qualification for management systems or knowledge More ❯

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 ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Preferred Qualifications: Experience building ML models with wearable data More ❯

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, IEC 62304) for medical devices Write clean, efficient, and well-documented code following best practices Participate in code reviews, testing, and continuous improvement initiatives More ❯

where everyone can thrive at work and beyond. Responsibilities Ensure compliance with regulations governing Software Medical Devices including ISO 13485, ISO 27001, and ISO 62304, as well as support for the Quality Management System (QMS) Author technical documentation, and designs and implements Medical Device validation protocols for Software focused More ❯

specifications to Verification and Validation protocols Preferred Qualifications: Strong understanding of industry best practices, global medical design standards, relevant FDA guidance (e.g. ISO-13485, IEC-60601, ISO-14971, IEC-62304, IEC-60812, ISO 62366, cybersecurity, etc). Experience supporting risk management activities (Hazards Analysis, UFMEA, DFMEA, etc. More ❯

teams, quality systems and product improvement projects for Beckman Coulter Life Science. Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout product lifecycle. Partnering cross functionally to ensure product and service conformance with particular focus on Design Controls More ❯

teams, quality systems and product improvement projects for Beckman Coulter Life Science. Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout product lifecycle. Partnering cross functionally to ensure product and service conformance with particular focus on Design Controls 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 ❯

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 ❯