11 of 11 Remote ISO 13485 Jobs

technical strategy. Develop novel approaches to overcome product development challenges. Maintain quality records across chemistry, consumables, and instrument activities. Ensure documentation complies with ISO 13485 requirements in collaboration with Quality. About You You ll bring a strong background in systems engineering within IVD, diagnostics or closely regulated medical … Excellent communication, documentation, and cross-functional collaboration skills. Strong root-cause analysis skills across electro-mechanical and instrument systems. Experience applying standards such as ISO 13485, IEC 62304, 21 CFR 820, IVDR, IEC 62366. Familiarity with ISO 14971 risk management (FMEA, FTA etc.). Broad engineering understanding ...

testing using automation and static code analysis tools. Debug hardware using oscilloscopes and logic analyzers. Ensure compliance with IEC 62304 , FDA , EU MDR , and ISO 13485 throughout development. Collaborate with multi-disciplinary teams in an Agile environment. Essential Skills Embedded firmware development experience (7+ years) with C/… EEPROM, micro-SD). Knowledge of secure bootloaders , firmware updates , and software architecture principles. Familiarity with IEC 62304 , FDA , EU MDR , and ISO 13485 compliance requirements. Ability to debug hardware using oscilloscopes and logic analyzers. Desirable Skills Experience with CI/CD pipelines , configuration management, and cloud-based ...

testing using automation and static code analysis tools. Debug hardware using oscilloscopes and logic analyzers. Ensure compliance with IEC 62304 , FDA , EU MDR , and ISO 13485 throughout development. Collaborate with multi-disciplinary teams in an Agile environment. Essential Skills Embedded firmware development experience (7+ years) with C/… EEPROM, micro-SD). Knowledge of secure bootloaders , firmware updates , and software architecture principles. Familiarity with IEC 62304 , FDA , EU MDR , and ISO 13485 compliance requirements. Ability to debug hardware using oscilloscopes and logic analyzers. Desirable Skills Experience with CI/CD pipelines , configuration management, and cloud-based ...

Head Office in Basingstoke. What will you be doing? As Quality Assurance Engineer , you will provide Quality Assurance support to our Quality Management System (ISO13485:2016) whilst assisting meeting our Regulatory responsibilities. This role is offered on a hybrid basis, with the expectation of 3-4 days onsite per week. … duties: Supporting the Implementation, maintenance, continuous improvement, and support of Blatchford's Quality Management Systems (in line with ISO13485:2016) and the Medical Device Regulations). Collaborating across internal departments to provide Quality Assurance support. Participating in external Quality aud it activities . R epresenting QA for various projects across ...

Experience working with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

consider applicants from three backgrounds: Medical device specialists, experienced embedded software engineers with a background in medical, healthcare, or other regulated environments such as ISO 13485, IEC 62304, aerospace, automotive safety, and similar sectors Regulated industry engineers, with transferrable skills from other safety critical or regulated sectors ...