
Senior R+D Firmware Engineer - Diagnostics
- Cincinnati, OH
- Permanent
- Full-time
- Lead the architecture and design of custom embedded Linux platforms and OEM modules, ensuring performance, security, and scalability.
- Architect the software framework for diverse connectivity options, including advanced BLE features and next-generation wireless technologies.
- Own the strategy for the full software lifecycle, including secure boot and robust over-the-air update mechanisms.
- Mentor a team of engineers on best practices for embedded Linux development and real-time design.
- Lead the resolution of complex, system-level issues involving hardware, kernel, and user-space interactions.
- Collaborate cross-functionally with software, cybersecurity, and other engineering teams during product design, development, and post launch sustaining activities.
- Drive the formal software documentation and verification strategy, ensuring all development activities and artifacts are compliant with FDA design controls and QMS (ISO 13485 / 21 CFR 820).
- Ensure documentation is accessible and understandable by cross-functional teams.
- Makes critical decisions regarding firmware architecture, technology stack, and implementation strategies.
- Ensure firmware reliability and resilience in critical applications.
- Establish and maintain standardized processes, analyzes process metrics.
- Influences change across disciplines and functions.
- Establishes and enforces quality standards; participates in quality improvement initiatives.
- Expertise in building and customizing embedded Linux systems. Deep knowledge of the Linux kernel, device drivers, and the hardware abstraction layer that enables the OS on custom boards.
- Extensive experience with high-performance, ARM-based SoCs or System-on-Modules (SoMs).
- Expert in modern C++ and system design patterns for complex, multi-process applications.
- Proven experience architecting and shipping products with advanced wireless capabilities, particularly BLE.
- Deep, practical experience developing medical device software under FDA (21 CFR 820) and international (ISO 13485) regulations. Must have successfully led projects through formal design control processes.
- Demonstrated ability to lead technical projects, mentor engineers, and make critical architectural decisions.
- Provides leadership, coaching, and/or mentoring to level II and level III engineers.