Medical Device Quality Engineer
Posted on February 21, 2026 (3 months ago)
Medical Device Quality Engineer
Our mission is to hasten the transition to universally accessible healthcare. We are authorised by governments to assess and grant market access to medical AIs. Our approach enables the most innovative technology to reach patients safely and quickly. Scarlet is the pre-eminent authority on AI medical devices, serving customers building bleeding-edge medical AI systems. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.
About this role:
Scarlet’s Quality Team ensures Medical Device Manufacturers meet and exceed Quality Management System (QMS) requirements set by regulators. The team designs efficient workflows to enable timely and secure QMS audits of next-generation Healthtech products. The Quality Team's goal is full compliance and operational excellence—both within Scarlet and for Medical Device Manufacturers.
Your responsibilities:
- Get authorised to audit and certify the quality management systems of innovative healthcare companies
- Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.)
- Optimise the assessment of customer data by designing efficient audit processes
- Maintain and expand Scarlet’s approvals in various jurisdictions and technologies
The key skills:
- Education: Bachelor’s degree in engineering, software engineering, computer science, physics or equivalent
- Minimum of four years of professional experience in the field of medical devices
- Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971)
- Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971)
- Minimum one year of practical experience working with medical device software, with knowledge of IEC 62304, IEC 82304, software development methodologies, and cybersecurity
Desirable skills:
- Experience working with ISO 27001
- Ability to read and interpret normative texts and extract essential requirements
- Curiosity and willingness to investigate deeply and challenge the status quo
- Adaptability and ability to operate autonomously in ambiguous environments
The Interview Process
Interview stages: Recruiter screen and intro call with hiring manager (45 mins); Regulatory and Auditor Skills interview with Quality Team (45 mins); Cross-functional Problem Solving interview with Operations Team (45 mins); Founder interviews (2 x 30 mins); References; Offer.
Compensation Range: £60K - £80K
How to apply
Please apply via the application link on the job posting by clicking the "Apply for this Job" button on the listing.
Application details
You will be guided through the application form after clicking apply. The interview process details are listed on the job posting.