Job Description
Description
Directly support the commercialization of a newly FDA-approved, life-saving cardiovascular device Gain exposure to quality, manufacturing, and engineering teams within a Class III device environment Opportunity to build experience in structural heart / catheter-based technologies, a highly specialized and in-demand space Perform in-process, functional, and final inspections of transcatheter heart valve (THV) devices Conduct microscope-based inspection of valve components and assemblies Execute functional and hydrodynamic testing related to valve performance Review and audit Device History Records (DHRs), manufacturing documentation, and process logs Support sterilization preparation activities and ensure product readiness for final release Inspect final packaging and labeling to ensure compliance with specifications and quality standards Identify defects, document findings, and escalate quality issues as needed Maintain accurate documentation in compliance with GMP,...
Directly support the commercialization of a newly FDA-approved, life-saving cardiovascular device Gain exposure to quality, manufacturing, and engineering teams within a Class III device environment Opportunity to build experience in structural heart / catheter-based technologies, a highly specialized and in-demand space Perform in-process, functional, and final inspections of transcatheter heart valve (THV) devices Conduct microscope-based inspection of valve components and assemblies Execute functional and hydrodynamic testing related to valve performance Review and audit Device History Records (DHRs), manufacturing documentation, and process logs Support sterilization preparation activities and ensure product readiness for final release Inspect final packaging and labeling to ensure compliance with specifications and quality standards Identify defects, document findings, and escalate quality issues as needed Maintain accurate documentation in compliance with GMP,...