1 to 25 of 26 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 ❯

to be undertaken in accordance with industry standards and working within an ISO 13485 quality management system relevant to a class 2b device under IEC 62304, IEC (phone number removed) and IEC (phone number removed) Person Specifications as a Software Engineer: A Full-Stack Developer- Software More ❯

to be undertaken in accordance with industry standards and working within an ISO 13485 quality management system relevant to a class 2b device under IEC 62304, IEC (phone number removed) and IEC (phone number removed) Person Specifications as a Software Engineer: A Full-Stack Developer- Software 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 ❯

company across embedded systems, software platforms and data architecture. Oversee development and integration of both hardware and software systems in compliance with ISO 13485, IEC 62304, MDR, and FDA requirements. Build and manage the internal engineering team and collaborate with external technical partners and suppliers. Drive the product … hardware technology development for highly regulated environments - ideally medical devices. Hands-on experience with: Embedded systems and hardware-software integration Software lifecycle development under IEC 62304 System design & cybersecurity Design Control & Risk Management per ISO 14971 Experience with agile product development in a scale-up or startup is 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 ❯

Clearance required to start Key Skillset Essential: C/C++ Java Large Distributed System Software Design Significant experience safety critical or safety related systems (IEC 61508 ideal/IEC 62304 or IEC 26262 possible) Significant knowledge of high integrity coding practices and tooling (Unit test, Static More ❯

Clearance required to start Key Skillset Essential: C/C++ Java Large Distributed System Software Design Significant experience safety critical or safety related systems (IEC 61508 ideal/IEC 62304 or IEC 26262 possible) Significant knowledge of high integrity coding practices and tooling (Unit test, Static More ❯

Clearance required to start Key Skillset Essential: C/C++ Java Large Distributed System Software Design Significant experience safety critical or safety related systems (IEC 61508 ideal/IEC 62304 or IEC 26262 possible) Significant knowledge of high integrity coding practices and tooling (Unit test, Static 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 ❯

to the full software development life cycle, including requirements analysis, design documentation, and validation Ensure compliance with medical standards such as ISO 13485 and IEC 62304 Support verification and validation activities, including unit testing and documentation Participate in regular code reviews and technical discussions with cross-functional teams 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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯