Systems Engineer

Toronto
Quality Assurance & Regulatory Affairs
Full Time Employee
Our mission

Ezra’s mission is to detect cancer early for everyone in the world. Our customers (we call them members) sign up for an Ezra full-body MRI scan at ezra.com, visit a partner imaging facility to get their scan, and receive their report from an Ezra Medical Provider within 7 days. We are live in New York, San Francisco Bay Area, and Los Angeles. In 2019, we helped 29 of our members detect cancer.

We're also building AI technology designed to assist radiologists in their analysis of MRI images & to increase their productivity. Our first AI was created to assist radiologists when analyzing prostate MRI scans, and is currently under FDA review.

Your mission

You will join a team of creative people working on pioneering technologies. As a Systems Engineer at Ezra, you will ensure the compliant development of the next generation of cloud-based AI services for early cancer detection. You live and breathe the risk-based approach. You have experience guiding software teams in a highly-regulated environment. You thrive on dotting your I’s and crossing your T’s and you’re a great listener. You also have a great work ethic and are always learning about the latest quality standards.

As our Systems Engineer, you will:

    • Provide quality-related guidance to ensure compliant development of software as a medical device (SaMD)
    • Guide on the interpretation of applicable standards, guidelines and guidance documents as they impact the design and development planning, design requirements and product specifications, design verification planning, etc.
    • Guide teams through the risk management process throughout all stages of software development
    • Assist with design review meetings, records and maintain the DHF
    • Participate in team brainstorms and contribute with solutions to challenging and interesting quality & regulatory problems
    • Work in a regulated Agile environment
    • Learn about medical imaging, radiology, cancer and artificial intelligence.

Key requirements:

    • 5+ years of experience in 21 CFR Part 820, IEC 62304 and ISO 14971
    • 5+ years of experience in Design Assurance or Quality Engineering leadership
    • Experience working in a regulated software development environment
    • Excellent risk-based thinking

Nice to haves:

    • Experience with international regulatory submissions
    • Experience with effective SOP development and quality objectives
    • ASQ or RAPS certification


What’s in it for you?

You have the opportunity to be an early employee at Ezra and be part of an all-star team focused on detecting cancer early for everyone in the world. Our employee benefits include: comprehensive health, dental and vision plans for your and your family; wellness and commuter benefits; competitive vacation policy; a culture that emphasizes learning and work-life harmony; healthy food and snacks; off-sites and happy hours.

Our commitment to diversity and inclusion

We’re aiming to build a diverse team and inclusive company culture. We are an equal opportunity employer (EOE) and do not discriminate based on race, color, ethnicity, ancestry, national origin, religion, sex, gender, gender identity, gender expression, sexual orientation, age, disability, veteran status, genetic information, marital status or any legally protected status.