9 of 9 IEC 62304 Jobs in Oxfordshire

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 ...

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 ...

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 ...

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 ...