Reviews (CDRs). Collaborate with V&V teams to support defect triage, issue resolution, and validation. Monitor regulatory changes and ensure compliance with standards such as IEC 60601 and ISO 14971. Conduct risk management activities including FMEA and hazard analysis. Champion continuous improvement across engineering tools and processes. Required Experience & Qualifications Essential: Bachelors degree in biomedical, mechanical, electrical, or … systems engineering (or equivalent). Strong background in high-reliability systems (e.g., ventilators). Deep understanding of ISO 14971 and IEC 60601-1 standards. Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release. Familiarity with ISO/IEC/IEEE 15288 lifecycle within regulated product development. Comfortable working in cross-functional teams and dynamic … project environments. Desirable: Experience in ISO13485-compliant environments. Knowledge of real-time control systems and embedded platforms. Experience in IEC 62304 Strong communication and collaboration skills across engineering, quality, and clinical teams. More ❯
product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers’ technical support activities. Hands-on More ❯
product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers’ technical support activities. Hands-on More ❯
documentation. + Contribute to risk management (FMEA, hazard analysis) and V&V. Key skills: + Strong knowledge of systems engineering lifecycle. + Skilled in risk management and regulatory compliance ISO 1497. + Experience of R&D in a regulated environment, ISO13485 would be beneficial. The salary will be up to £75k depending on previous experiencewith great More ❯
Comfortable using tools like Jira, TestRail, and writing technical documentation Experience working in cross-functional teams with QA, Product, and Regulatory Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯
