scarlet - Medical Device Quality Engineer

• Education: Bachelor’s degree in engineering, software engineering, computer science, physics or equivalent. • Work experience: Minimum of four years of professional experience in the field of medical devices and a minimum of two years of professional experience specifically in quality management within this sector (e.g., ISO 13485). Experience auditing against these requirements is also required. Additionally, one year of practical experience working with medical device software demonstrating knowledge of relevant standards such as IEC 62304 and cyber security practices like those outlined in ISO 27001 are desirable skills but not explicitly stated job requirements. • Technical experience: Minimum one year of practical experience working with medical device software, understanding the relevant requirements (e.g., IEC 62304), and demonstrating knowledge of software development methodologies is a desired skill rather than an explicit requirement for this role as per the provided job posting text. • Analytical reader: Being comfortable reading normative texts and analyzing/interpreting them to extract essential information, while desirable in understanding complex regulations like ISO 13485 or EU MDR, is not explicitly stated as a requirement for this role within the given job posting content.