Senior R&D Engineer, Medical Devices - Quality & Compliance

ECI, a leading life sciences consulting firm, seeks a senior Quality/Regulatory professional in Minnesota to drive quality systems, regulatory compliance, and product lifecycle support for medical devices. You will lead design reviews, V&V, and CAPA activities across projects, ensuring FDA and ISO alignment, and mentor teams in advanced statistical methods. Ideal candidates have extensive experience with cardiac devices, experience with Class III FDA, and strong technical writing skills.