Jobs at iota Biosciences, Inc. powered by Astellas

The Staff Firmware Engineer will lead firmware architecture and development for implantable devices, focusing on BLE security and regulatory compliance. Responsibilities include defining standards, mentoring engineers, and optimizing firmware for safety and performance across product lifecycles.

Lead and align engineering, manufacturing, and product development to support PMA, clinical studies, and commercialization. Advise the CEO and executive team on technical risk, resource allocation, and strategy. Grow engineering leadership across electrical, firmware, software, systems, mechanical, and manufacturing. Ensure design controls, risk management, verification/validation, and cross-functional execution with Quality, Regulatory, Clinical, Operations, and Product teams.

As Staff Firmware Engineer, you'll lead the firmware architecture strategy, develop embedded software for medical devices, and ensure compliance with medical regulations. You'll collaborate with cross-functional teams and optimize processes.

Lead and manage clinical operations for global Class III implantable device studies. Oversee study planning, site activation, vendor/CRO management, monitoring, regulatory compliance (GCP), cross-functional coordination, and post-clinical support to enable clinical execution and product launch.