
Senior R+D Electrical Engineer - Diagnostics
- Cincinnati, OH
- Permanent
- Full-time
- Lead the hardware architecture for systems utilizing high-performance, ARM-based solutions.
- Drive the technology selection and integration strategy for next-generation wireless, including advanced BLE features and other innovative communication hardware.
- Own the architecture for the entire system, optimizing for battery life, efficiency, thermal performance, and electrical safety.
- Serve as the technical authority for all hardware design aspects, from concept to manufacturing, including simulation, validation, and complex troubleshooting.
- Mentor other hardware engineers and provide technical oversight on all designs.
- Own the hardware compliance strategy, ensuring designs meet all requirements for FDA (21 CFR 820), ISO 13485, and IEC 60601-1, and act as a key technical resource during regulatory reviews.
- Design complex PCB assemblies and test fixtures to support development, verification, and manufacturing needs.
- Manage technical relationships with hardware component vendors and contract manufacturers.
- Identifies opportunities for cost savings without compromising quality.
- Ensures that documentation complies with company standards and industry regulations.
- Applies domain mastery to the application and advancement of engineering methods and tools.
- Establishes and enforces quality standards; participates in quality improvement initiatives.
- Deep expertise in design for manufacturing (DFM).
- Expert-level proficiency with Altium Designer.
- Mastery of high-speed digital design, signal integrity (SI), and power integrity (PI).
- A strong system-level perspective, with the ability to manage complex technical trade-offs.
- Expert-level knowledge and application of medical device hardware standards (IEC 60601-1) and development within a 21 CFR 820 compliant QMS.
- 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.