Two Sigma Ventures

At WHOOP, we're on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.

WHOOP is seeking a Lead Software Design Quality Engineer (Medical Devices) to navigate and manage regulatory and quality processes in support of product development for Medical Device Software, including the implementation and execution of a Software Development Lifecycle (SDLC) process in alignment with US FDA Quality System Regulations and Design Controls. In this role, you will work with the WHOOP Medical Device Team to act as a champion of Quality Assurance and Regulatory activities throughout the SDLC process.

As a Lead Software Design Quality Engineer, you will be responsible for various quality functions in support of product development for Medical Software, such as leading Risk Management activities, collaborating with the WHOOP Medical Device Team throughout the SDLC, mentoring team members through Design controls, and ensuring compliance with the Quality Management System (QMS). You will hold yourself and the team accountable for developing best-in-class, safe, and effective medical devices that address customer and regulatory requirements. Additionally, you will need to bring best practices and creative problem-solving abilities to support high-speed medical development in a consumer wearable company.

This role reports to the Director of Quality and Regulatory Affairs.