Athelas One — Class II AI/ML Blood Analyzer

Led design revision and execution of a Class II medical device, delivering a production-ready update in 6 months while reducing test time by 18% and BOM cost by 13%.

Built automated lifecycle and manufacturing test infrastructure, increasing validation throughput by ~300%.

Scaled manufacturing systems and BOM management to support deployment of 3,000+ devices.

Developed embedded firmware (ARM/Linux, microcontrollers) for motion control and diagnostics, improving field reliability and reducing in-field failures.

Diagnosed and resolved electronic quality issues via RMA analysis, increasing manufacturing pass rates by 12%.

Created internal diagnostic and monitoring tools (SQL, JavaScript, Retool) enabling real-time fleet health visibility and faster root cause analysis.

Technical owner for hardware and firmware of a Class II blood analyzer in a regulated manufacturing environment.

Developed embedded firmware (ARM/Linux) for motion control and telemetry, plus automated manufacturing test systems.

Led V&V activities under ISO 13485/MDSAP, including risk management, traceability, and failure analysis (RMA → CAPA/ECO).

Supported hardware architecture, component selection, and DFM/DFA through production ramp.

Designing within Class II medical device regulatory constraints while preserving rapid iteration cycles.

Balancing BOM cost reduction with component availability, reliability, and long-term supply stability.

Reducing manufacturing yield variability through automated test and validation systems.

Bridging gaps between lab performance assumptions and real-world environmental variability (temperature, vibration, shipping).

Hardware: PCB design, DFM/DFA, BOM management, manufacturing scale-up

Firmware: ARM, Linux, microcontrollers, motion control, telemetry

Quality & Regulatory: ISO 13485, MDSAP, V&V, risk management, CAPA

Manufacturing & Test: Automated test systems, lifecycle validation, yield optimization

Data & Tooling: Python, SQL, JavaScript, Retool