Active Device Specialist at Creandum-backed medical AI authority

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.

• 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.

• 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.

• 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.