6 of 6 ISO 13485 Jobs in the East of England

assays and how to deliver products to manufacture. Strong communications skills for stakeholder collaboration, technical leadership and mentorship. Familiarity with relevant industry standards including ISO 13485, ISO 14971, 21CFR part 820 and MDR. This is a senior, technical lead role with expectations of hands-on experience. Projects … projects allow). Some international travel would be required for client visits. Keywords: Applied Life Sciences, Systems Engineering, PoC, In Vitro Diagnostics, Instrumentation Development, ISO 13485, ISO 14971, Technical Leadership, Mentoring, Commercial Aptitude, Consultancy, Cambridge/Hybrid Another top job from ECM, the high-tech recruitment experts. ...

organisation. Present security risks and recommendations to senior leadership. Essential Experience 5+ years' experience in Information Security, Cybersecurity or Product Security. Strong experience with ISO 27001 and recognised frameworks such as NIST and OWASP. Experience conducting risk assessments, threat modelling and vulnerability management. Experience integrating security into software development … deliver pragmatic, risk-based solutions. Highly Desirable Medical Devices, HealthTech or Software as a Medical Device (SaMD). Product Cybersecurity experience. Knowledge of ISO 13485, ISO 14971, GDPR, HIPAA and FDA cybersecurity guidance. Experience with connected devices, mobile applications or cloud-hosted healthcare platforms. Qualifications Professional certifications ...

short notice. Support product testing and validation during New Product Introduction (NPI). Complete build sheets, QA records and validation documentation in line with ISO 13485 and ISO 9001 requirements. Maintain test equipment calibration and process spare parts returns. Support Field Service Engineers on customer sites once ...

development this cutting-edge medical device. Ideally, you will have worked within the Biotech or Medical Devices sectors previously and have knowledge of ISO 13485, IEC 62304 and ISO 14971. The company has the unique ability to offer an excellent benefits package, pension, medical insurance, life assurance ...

electronics, you can demonstrate significant industry experience in electronic hardware design including prototyping, ECAD, test and manufacturing. Project experience with medical device regulations (ISO13485). Other highly-regulated industry experience may be considered. Experience with FPGAs or Python for test automation would be desirable. Exposure to optics, embedded software ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...