Senior R+D Electrical Engineer - Diagnostics

JOB SUMMARY:

The Senior Hardware Engineer will own the hardware architecture for our patient monitoring platform and peripherals, leading all design activities. This role requires an expert who can define a clear technical vision and guide a team of engineers in its execution. You will lead the design of next-generation and existing medical products, making critical selections for core technologies while ensuring compliance with all medical device regulations. This position is expected to be in office 4 days a week at our Cincinnati location. This is not a remote position.

ESSENTIAL/PRIMARY DUTIES:

• 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.

SECONDARY DUTIES:

• 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.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in electrical engineering or related field and 6+ years of experience, or equivalent combination of both. Significant experience with integrating multiple wireless technologies onto a single platform, including antenna design considerations and coexistence strategies. Proven expertise in architecting hardware for portable, fixed, battery-powered, wireless and wired peripherals. A history of technical project leadership and mentoring. Experience designing analog front-ends for signal acquisition. Experience designing hardware for location-aware technologies. Experience with medical device risk management (ISO 14971) for hardware.

COMPETENCY and/or SKILL:

• 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.

SUPERVISORY RESPONSIBILITIES:

• Provides leadership, coaching, and/or mentoring to level II and level III engineers.