Teams at Capstan Medical

Support structural heart valve product quality from development through production readiness and release. Lead design controls, risk management, verification/validation, sterilization and microbiology testing, acceptance activities, cleanroom operations, CAPA/NCR/MRB, and continuous improvement. Collaborate cross-functionally with R&D, Operations, Regulatory, suppliers, and labs to ensure compliance with device quality systems and applicable standards.

Lead design and implementation of end-of-line, hardware-in-the-loop, and CI/CD test frameworks for capital, implant, and delivery systems. Integrate and debug hardware/software, run stress/load tests, aggregate manufacturing and field data for analysis, and provide actionable feedback to engineering teams to improve design, manufacturing consistency, and clinical performance.

Support and manage medical device clinical studies for mitral and tricuspid valve products. Oversee site start-up, monitoring, data entry/query resolution, regulatory/IRB submissions, CRO management, safety event reporting, TMF and CTMS maintenance, site payments, and coordination of CEC/DSMB activities. Collaborate cross-functionally to ensure compliance and study progress.