Teams at ECHO AI

Drive software design control and regulatory documentation for Class III medical device software. Author SRS, architecture, traceability, and risk files; ensure IEC 62304/ISO 13485/FDA compliance; produce V&V protocols and reports; prepare regulatory submission materials; and maintain post-market documentation and CAPA support.

Design and implement end-of-line and in-process manufacturing test systems for hardware products. Create test plans, build PCB-level fixtures and mechanical interfaces, develop automation (LabVIEW/Python), validate and optimize test systems, analyze failures, support scaling to production, and coordinate with cross-functional teams and contract manufacturers.

Lead and mentor engineers building mobile and desktop apps integrated with devices, cloud, and ML. Drive engineering best practices, technical strategy, cross-functional collaboration, and documentation with Quality and Regulatory to translate research into production medical software.