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Summary
About the Role
About You
- Bachelor’s degree in engineering, life sciences, or a related technical discipline.
- Lead Auditor certification for ISO 13485:2016.
- Minimum 4 years in a QA leadership role within the medical device industry.
- Minimum 10 years of progressive experience in quality assurance roles in the medical device sector.
- Experience with portable imaging devices or complex electromechanical systems.
- Participation in successful 510(k) submissions and CE Marking of Class II or III devices.
- Familiarity with human factors engineering and usability studies in the medical device context.
Benefits
- Competitive annual base salary between $150k–$175k.
- Eligibility to participate in Hyperfine's corporate bonus and equity plans.
The Swoop® system brings MR brain imaging within reach. Our mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions. Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking medical technology company that has redefined brain imaging with the Swoop® system—the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020. It is a portable ultra-low field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.