Medical Device Quality Engineer - AI, Scarlet

Software & AI Medical Devices

£60-80k

Mid and Senior level
Remote in EU, UK
London
Scarlet

Specialised certification of medical AI and software

Open for applications

Scarlet

Specialised certification of medical AI and software

21-100 employees

HealthcareB2BArtificial IntelligenceComplianceSaaSRegtechMedTech

Open for applications

£60-80k

Mid and Senior level
Remote in EU, UK
London

21-100 employees

HealthcareB2BArtificial IntelligenceComplianceSaaSRegtechMedTech

Company mission

To hasten the transition to accessible, affordable healthcare for everyone on the planet.

Role

Who you are

  • 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
  • Technical acumen - Minimum of one year practical experience working with AI

Desirable

  • 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

What the job involves

  • 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

Application process

  • 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!

Salary benchmarks

Our take

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.

After working closely with regulators, Scarlet has received the key designations that allow them to certify medical software, and do so in a software-focused way. This makes for a much more efficient process, and caters to the frequent updates inherent to good software. It means new products can be updated and released often, ensuring patients can safely get the most up-to-date technology.

Kirsty headshot

Kirsty

Company Specialist

Insights

Strong hiring activity
Top investors

Most candidates hear
back within 2 weeks

Company

Employee endorsements

Meaningful work

"Healthcare technology has always been a few years behind the new cutting-edge technology we see in other fields. Helping medical device software to..."

Funding (last 2 of 3 rounds)

Jun 2024

$17.5m

SERIES A

Aug 2022

$7.9m

SEED

Total funding: $27.4m

Company HQ

Marylebone, London, UK

Founders

James Dewar

(Co-founder)

Previously a Data Scientist at Smarkets and Senior Data Scientist at Babylon Health. Worked extensively on software medical devices.

Jamie Cox

(Co-founder)

Originally studied medicine before becoming a software engineer. Previously was a Software Engineer at Babylon Health.

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