17 of 17 IEC 62304 Jobs in the South East

design, development, risk assessment, and change control. They will provide Quality and Design Assurance oversight across the software lifecycle for medical devices, including IEC 62304 software and digital health applications. The role works closely with Regulatory Affairs to ensure software documentation and procedures meet applicable standards and regulatory … Assure software quality throughout the full lifecycle process in accordance with OrganOx software standards and procedures for software up to safety class C per IEC 62304. Ensure effective implementation of software design controls, including requirements, architecture, verification and validation, configuration management, change control and release management. Ensure appropriate traceability ...

device validation and compliance. The work could involve partnering with cross-functional teams to design, execute and document validation activities under ISO 13485 and IEC 62304, with scope to contribute to delivering devices that meet the highest regulatory standards. Typical role overview Location: London, Greater London, England Type … responsibilities could include: Supporting the design and execution of system validation protocols and test cases Conducting validation testing and documenting results in compliance with IEC 62304 and ISO 13485 Coordinating with engineering, quality and regulatory teams to ensure validation completeness Preparing validation reports and supporting regulatory submissions Contributing ...

full software development lifecycle, including requirements definition, architecture, implementation, testing, and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, and other relevant safety standards. Establish and enforce high-quality software engineering practices, including code reviews, architectural governance, and design best practices. … tools to accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

firmware integration Carry out regression testing and release verification for a product on the market under design controls, in accordance with applicable standards including IEC 62304 and ISO 14971 Work with the Quality team to maintain traceability from verification to requirements and risk management, and to document test … extending a test harness Ability to communicate technical information clearly and to work well with engineers across disciplines Desirable skills and experience: Familiarity with IEC 62304 and ISO 14971, or equivalent standards in another regulated industry Hardware‐in‐the‐loop or test‐rig experience, including firmware‐level testing ...

designs using Altium Designer (advantageous). Performing component selection and design calculations to meet performance specifications. Conducting design verification and validation in accordance with IEC 60601 and other applicable standards. Collaborating with mechanical, software, and systems engineers to ensure seamless integration of electronics. Supporting prototype assembly, debugging, and troubleshooting. … design-for-manufacture principles. Experience with electronic testing tools such as oscilloscopes, spectrum analysers, and logic analysers. Understanding of medical device standards (ISO 13485, IEC 60601, IEC 62304) is an advantage. Ability to troubleshoot and solve complex design issues. Effective communication skills for working within cross-functional ...

development, and verification of electronic systems for Class III medical devices. Defining electronic architecture and component selection to meet performance, safety, and regulatory requirements (IEC 60601, IEC 62304, ISO 14971). Reviewing and approving schematics, PCB layouts, and technical documentation. Supporting system-level architecture decisions, particularly … regulated products (medical device experience strongly preferred). Strong background in both analogue and digital circuit design. Proven track record of designing to IEC 60601 and other relevant safety standards. Experience with PCB design tools (e.g., Altium Designer) and version control systems. Knowledge of power electronics, motor control ...

medical devices. The ideal candidate brings deep hands-on experience with DICOM-RT standards, network-level system integration, and medical device software development under IEC 62304. You will play a key technical leadership role in defining and implementing the interoperability architecture that connects our treatment delivery system … lead on significant software development projects spanning interoperability and clinical connectivity. Write specifications, requirements, design documents, and test protocols for software projectsin accordance withIEC 62304 and thecompanydesign control process. Develop safety-critical software for imaging and treatment delivery systems. Work with external partners and clinical customers to develop,validate ...

future product development, influencing firmware architecture and technical decisions. Ensuring firmware is developed, tested and documented to meet medical device regulatory requirements, including IEC 62304. Building the foundations for bringing firmware development in-house. Contributing hands‐on to development, debugging, testing and problem‐solving. Collaborating with electronics, software, quality … regulated products, ideally in medical devices or aerospace/aviation . An understanding of structured software development, verification, traceability and regulatory documentation. Experience with IEC 62304 or DO‐178C would be particularly relevant. Knowledge of low‐power, battery‐operated devices and Bluetooth Low Energy (BLE). The confidence ...

Software as a Medical Device (SaMD) sector. Strong understanding of software risk management and functional safety principles. Knowledge of standards such as ISO 14971, IEC 62304, and related medical device regulations. What's on Offer Up to £85,000 Share option scheme Hybrid work arrangement and flexibility ...

validation, configuration management and cybersecurity Strong communication skills and an interest in assessing technical evidence Advantageous: Knowledge of medical device software standards such as IEC 62304, although candidates from aerospace, automotive, defence and other safety-critical sectors are also encouraged to apply Tremendous opportunity offering plenty of scope ...

safety-critical environments Knowledge of software development lifecycle (SDLC), verification & validation, configuration management, and cybersecurity Experience with medical device software standards such as IEC 62304 is advantageous Offering Salary: £80,000-£85,000 Location: London - 2/3 days per week in office Opportunity to work on cutting ...

mentoring junior members of the team. Promote automation-first thinking within the testing team. Compliance with the MDD/MDR and ISO 13485/62304 standards for validation and verification of software medical devices. Skills & Experience Required: Essential Strong Python programming skills, including object-oriented programming and clean code ...

shared Digital/Data needs (essential) Strong communication, stakeholder‐management, technical leadership and mentoring skills across technical and non-technical teams (essential) Experience with IEC 62304, ISO 14971, or other regulated software development and risk‐management processes (desirable) Experience with connected medical device platforms, cloud‐hosted digital health ...

with quantitative or statistical acceptance criteria and data-driven testing. Biomedical, healthcare or digital-health experience. Experience in regulated medical technology environments. Familiarity with IEC 62304, ISO 13485 or related medical-device standards. Standard Employee Benefits Employee share option scheme 22 days' annual leave plus UK bank holidays ...

external partner work and laying the foundations for an in-house capability. You will influence architecture, ensure compliance with medical device standards such as IEC 62304, and collaborate with electronics, software, quality and regulatory teams to deliver safe, reliable products. #J-18808-Ljbffr ...

PACS. You will define interoperability architecture and lead cross-functional teams in a medical device context. The role requires deep clinical software experience, IEC 62304 expertise, and hands-on leadership in delivering safe, compliant medical software across complex workflows. #J-18808-Ljbffr ...

extend coverage across tests for medical device software validations. You will mentor juniors and promote automation-first practices while aligning with ISO 13485/62304 compliance requirements. #J-18808-Ljbffr ...