Active Device Specialist

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 groundbreaking approach enables the most innovative technology to reach patients safely and quickly.

Scarlet is the pre-eminent authority on AI medical devices. We serve customers that matter. Companies building bleeding-edge medical AI systems choose Scarlet. We are proud to count the world’s best resourced and most ambitious companies building medical AI as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.

Come help us bring the next generation of healthcare to the people who need it.

About this role:

Scarlet’s Devices function is a team of clinicians and software engineers, working together to assess and certify the most innovative and impactful medical device software.

We pride ourselves on delivering fast and efficient assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices.

We’ve proved our capabilities with medical device software. It’s now time to expand our remit to cover hardware medical devices.

You’ll be our first specialist with deep electrical/active-device expertise, tasked with charting a path towards fast and efficient active device assessments.

Your responsibilities:

• Get authorised to assess the technical documentation of the most innovative active devices in the world

• Builds Scarlet’s processes for assessing active medical devices

• Become Scarlet’s internal expert in active hardware medical devices, defending our processes to external experts.

• Incorporate relevant standards into the assessment process (e.g. the IEC 60601-1 family of standards)

• Optimise the assessment of customer data by designing efficient assessment processes

Key skills:

• Education - Bachelor’s degree or higher in biomedical engineering, electrical engineering, electrical and mechanical engineering, or similar

• Work experience - Minimum of four years of professional experience in the manufacturing, auditing or research of active medical devices

• Work experience - Minimum of two years of professional experience in the design, manufacture, testing of active medical devices

• Work experience - Knowledge of, and experience implementing, the IEC 60601-1 family of standards (or a relevant subset thereof)

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

• Excellent communicator - You have exceptional written & verbal communication skills

• Hardware expertise - You have knowledge of implantable devices, biocompatibility and sterilisation, including relevant associated standards (e.g. the ISO 10993 series)

The interview process:

1. Intro call with Sandy - 20 mins

2. Interview with Tiri and a member of the Devices function - 2 x 30 mins

3. Technical interview with Sandy - 1 hour

4. Culture and values interview with James and Jamie - 2 x 30 mins

5. Referencing & offer