Overview

If you have ever wanted your engineering work to directly save lives, this is your moment. Bayesian Health is scaling up rapidly, and we need a Senior Design Quality Engineer to join our fully remote team from anywhere in the world. You will take charge of safeguarding product quality for our FDA-cleared, AI-driven clinical platform. From managing design controls during the build phase to digging into post-market complaint investigations in active hospitals, your footprint will be everywhere. You will collaborate with top-tier clinicians, data scientists, and builders who are backed by industry heavyweights like Andreessen Horowitz and Obvious Ventures.

Key Responsibilities

Own and drive design control processes for our cutting-edge AI clinical platform as it evolves.
Oversee rigorous risk management activities in compliance with medical device standards.
Investigate post-market complaints and feedback from hospital floors with care and precision.
Maintain and optimize the quality management system and regulatory records that keep our operations compliant and robust.
Partner closely with product, engineering, and clinical teams to embed quality principles early and often.

Requirements

Extensive background in quality engineering within the medical device, software as a medical device, or heavily regulated tech space.
Solid working knowledge of FDA regulations, ISO 13485, and design control best practices.
A deep passion for healthcare technology and a desire to make patient care more proactive through data.
Exceptional problem-solving abilities and a knack for translating complex regulatory requirements into practical workflows.
Clear communication skills to collaborate effectively across a distributed global team.

What You'll Gain

The chance to work on award-winning technology recognized by Forbes and the World Economic Forum.
A fully remote work environment offering ultimate flexibility on a worldwide scale.
Competitive compensation and ownership in a rapidly growing, well-funded startup.
Daily opportunities to collaborate with world-class clinicians and AI pioneers.