Senior R+D Electrical Engineer - Diagnostics
Listed on 2025-10-08
-
Engineering
Systems Engineer, Hardware Engineer, Electrical Engineering, Electronics Engineer
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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.
- 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.
Job Description
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.
- 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.
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…
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