Cancer screening without barriers. Backed by Y Combinator.
About the role
We're looking for a Senior Quality Engineer to own quality on a mid-field MRI system as we drive toward a 510(k) submission. This is a foundational hire: you'll stand up and run the quality management system, design controls, and risk management that turn breakthrough engineering into a safe, cleared medical device — and you'll set the standard the rest of the team builds to.
What they're looking for
- General Requirements:
- Strong problem-solving skills and exceptional attention to detail
- Ability to work independently and lead cross-functionally in a fast-paced startup environment
- Clear written and verbal communication, including the ability to write technical and regulatory documents and advise leadership
- Open to candid, constructive criticism
- Self-starter comfortable operating with ambiguity and little precedent
More about this role
We're looking for a Senior Quality Engineer to own quality on a mid-field MRI system as we drive toward a 510(k) submission. This is a foundational hire: you'll stand up and run the quality management system, design controls, and risk management that turn breakthrough engineering into a safe, cleared medical device — and you'll set the standard the rest of the team builds to. You'll work hands-on and cross-functionally with engineering, advise leadership on regulatory strategy, and be the person accountable for getting us to submission the right way. If you're a senior quality professional who wants ownership from day one, thrives in a fast-paced startup, and wants to see your work reach patients — this is for you. This is not your typical quality role. You will lead and shape our strategy, have true impact, and not sit on the sidelines.
- Comprehensive health and dental coverage
- 401(k) with company match (100% on first 3% contributed, 50% on next 2%, up to 4% total)
- Daily lunch provided
- Monthly gym membership reimbursement
- PTO: Unlimited
- Stand up and maintain our quality management system, aligned to ISO 13485 and the FDA Quality Management System Regulation, or QMSR...
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