Gentuity
This role involves developing and leading the Design Verification and Validation (V&V) plan for medical devices, ensuring compliance with regulatory standards like 21 CFR Part 820 and ISO 13485. The position requires defining test strategies, overseeing test execution, and managing documentation for mechanical, electrical, and system-level performance. It also includes leading test lab operations, mentoring engineers, and collaborating with cross-functional teams to support product development and regulatory submissions.
Headquarters
Sudbury, Massachusetts, United States
Gentuity is a medical technology company pioneering next-generation intravascular imaging through high-frequency OCT (HF-OCT) and ultra-low-profile catheter technology. Their HF-OCT Imaging System and Vis-Rx PRIME Micro-Imaging Catheter provide interventional cardiologists with complete coronary artery visualization and real-time insights to optimize PCI procedures. The company serves the cardiovascular medical device industry, with solutions becoming available through GE HealthCare in the United States.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for Gentuity.
Gentuity didn’t post a salary, so this is our estimate from similar listings.