Medical Device Quality Engineer - Software Proucts

at  Scarlet

OUR PHILOSOPHY

Hastening the transition to universally accessible and affordable healthcare requires a specialised and deeply ambitious approach, to ensure the leading innovators, those pulling forward the future of healthcare, can safely get the best versions of life-changing technology to the people who need it.

THE KEY SKILLS:

• 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 SKILLS:

• Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information
• Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo
• Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks

ABOUT THIS ROLE:

Following our receipt of government designations allowing us to perform conformity assessments for software and AI medical devices in the UK and Europe, we are now scaling our team of Clinical Assessors. 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).

YOUR RESPONSIBILITIES:

• 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

At Scarlet, we have built our interview processes to ensure you get to fully understand the role and Scarlet’s culture, and to ensure we get to know about your skills, expertise, and who you are. Here is what to expect:

• Recruiter Screen with Talent Team - 30 mins
• Live Skills Interview with Quality Team - 45 mins
• Live Crossfunctional Interview with Operations Team - 45 mins
• Technical Interview with Solutions Architect - 45 mins
• Founder Interviews - 2x30 mins
• Offe