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Growth-focused medical device manufacturer with an active R&D operation in Cincinnati is seeking an Electrical Engineer to support the ongoing development of a hospital-based respiratory therapy system. This role supports a reusable, FDA-regulated capital device used in clinical settings.
Job Responsibility:
Design, maintain, and troubleshoot analog and digital circuits for a hospital-grade medical device
Own PCB development end-to-end, including schematic design, layout, prototype bring-up, and testing
Support power system design, battery management, and hardware interfaces to embedded firmware
Integrate and validate wireless/RF modules within a regulated product environment
Collaborate closely with mechanical, firmware, systems, and regulatory engineers across the product lifecycle
Develop and maintain technical documentation required for FDA submissions, including DHF content
Support verification and validation activities, including electrical safety and EMI/EMC testing
Requirements:
5+ years of electrical engineering experience on FDA-regulated medical devices (capital equipment preferred)
Hands-on experience working under FDA design controls (21 CFR Part 820), including DHF documentation
Strong background in analog and digital circuit design
PCB design experience using professional EDA tools (Altium, OrCAD, PADs, or similar)
Familiarity with IEC 60601 and ISO 13485 environments
Bachelor’s degree in Electrical Engineering or a closely related field
Nice to have:
RF / Wi-Fi (802.11 a/b/g) module design or integration experience
EMI/EMC and electrical safety testing exposure
Motor control or analog/digital sensor interface design experience
Embedded systems or firmware development exposure
ISO 14971 risk management experience
Background in respiratory, patient monitoring, or other hospital capital equipment