Medical Device Quality Engineer, Scarlet

• 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, or related activities, such as in manufacturing, auditing or research
• Work experience - Minimum of two years of professional experience in the area of quality management (e.g. ISO 13485, EU MDR, etc.)
• Technical experience - Minimum of one year practical experience in software, demonstrating knowledge of one or more programming languages, software design, validation, testing and debugging techniques, and interactions between software and its environment

Desirable

• Whilst our existing team continues to develop Version 2 of our proprietary assessment tooling, we're hiring more Clinical Assessors to perform assessments on the next wave of cutting-edge Software as a Medical Device (SaMD)
• Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world
• Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, etc.)
• Design a seamless experience for quality and regulatory teams using Scarlet's submission tool
• Develop and implement assessment processes for AI management systems and relevant requirements (e.g. ISO 42001, ISO 23894, ISO 22989, etc.)
• Optimise the assessment of customer data by designing efficient audit processes
• Develop and implement Scarlet's internal assessment tools
• Be involved in maintaining and expanding Scarlet’s approvals in various jurisdictions and technologies

• 1. Apply via Otta
• 2. Introductory call with the Principal Quality Engineer
• 3. 45' Interview
• 4. 45' Interview
• 5. Call with co-founder
• 6. Referencing
• 7. Offer!

Total funding: $27.7m

Software is rapidly taking centre stage in the development of new medical technology. However the approach used to certify new solutions was optimised for hardware rather than software, restricting patient access to innovation. This is what health tech compliance company Scarlet is solving.