Active Device Specialist at Scarlet — VC-backed healthtech startup

As Scarlet’s first Active Device Specialist, you will pioneer the expansion from software into hardware medical devices. You’ll design assessment processes from scratch, evaluate technical documentation for innovative active devices, and serve as the internal authority on IEC 60601-1 standards, directly accelerating market access for life-saving medical technology.

• Lead the creation and optimization of Scarlet’s internal processes for assessing and certifying active medical hardware devices.
• Authorize and review technical documentation for cutting-edge active devices to ensure compliance with international safety and performance standards.
• Act as the primary technical expert in active devices, defending Scarlet’s methodologies to external regulatory authorities and global hardware manufacturers.

• Holds a Bachelor’s degree or higher in Biomedical, Electrical, or Mechanical Engineering with a deep understanding of active device architecture.
• Brings 4+ years of professional experience in manufacturing, auditing, or research specifically focused on active medical devices and hardware testing.
• Demonstrates expert-level knowledge of the IEC 60601-1 family of standards and experience implementing these requirements in a regulatory or design context.

• Rare opportunity to be the founding specialist for a new function, transitioning a successful software-focused Notified Body into the hardware space.
• Join a high-growth startup backed by top-tier investors like Creandum with exponentially growing revenue and established product-market fit.
• Significant impact on global healthcare by defining the regulatory path for the world’s most advanced medical hardware and AI-integrated devices.