Senior Design Assurance Engineer – Transcatheter Valve

4 C Medical Technologies is seeking a Senior Design Assurance Engineer to drive design controls, risk management, and DHF maintenance for a transcatheter mitral heart valve system. You will support regulatory submissions and audits, coordinate across R&D, Clinical, Operations, and Regulatory Affairs, and mentor junior engineers in a fast-paced environment.

This role focuses on ensuring QMS compliance, managing DHF documentation, and contributing to PMA/CE Mark activities as the project advances.