As the first active hardware specialist, you will spearhead the expansion from software into physical medical devices. You will design and implement the assessment processes for the world’s most innovative hardware, ensuring they meet rigorous safety standards. This is a pioneering role within a high-growth firm currently experiencing exponential revenue growth.
Active Device Specialist at Scarlet
Are you an engineer with deep expertise in active medical devices? A high-growth, Creandum-backed healthtech leader is looking for their first Active Device Specialist to bridge the gap between AI software and hardware certification. You will have the unique opportunity to build an entire assessment function from the ground up, defining how the world's most innovative medical hardware reaches patients. With exponential revenue growth and a government-backed mandate, this London-based role offers a rare chance to shape the future of healthcare infrastructure while receiving meaningful equity and a pioneering leadership mandate.
About this role
Role overview
About the company
Scarlet
Creandum-backed healthtech startup authorized by governments to grant market access to AI medical devices
What you'll do
What you will do
- Define and build the end-to-end internal processes for assessing active hardware medical devices from scratch.
- Lead technical documentation assessments for cutting-edge active devices, ensuring compliance with the IEC 60601-1 family of standards.
- Serve as the internal subject matter authority, defending assessment methodologies to external experts and optimizing customer data evaluation workflows.
Who you are
Who this is a fit for
- Holds a degree in biomedical or electrical engineering with at least four years of professional experience in manufacturing, auditing, or research of active devices.
- Possesses a minimum of two years of hands-on experience in the design, manufacture, or testing of active medical hardware.
- Demonstrates deep technical knowledge of the IEC 60601-1 family of standards and an ability to interpret complex normative requirements.
Why this role
Why this role is remarkable
- Become the founding specialist for the company’s new hardware assessment function, moving from a proven software model into global physical device certification.
- Join a mission-driven team backed by top-tier investors like Creandum, operating with strong product-market fit and a direct mandate from government authorities.
- Work at the unique intersection of electrical engineering and regulatory innovation, shaping how the next generation of healthcare technology reaches the market.
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