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.

Lead clinical development activities for a transcatheter medical robotics platform: design and pre-clinical testing, support clinical trials and data collection, analyze clinical data, collaborate with physicians and cross-functional teams, and assist technical documentation and regulatory-aligned processes.