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.
Responsibilities
- 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 environmenCollaborate 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
Qualifications (must possess a minimum of 3 requirements below)
- 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
Preferred
- 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
Why This Role
- Work on an FDA-cleared, hospital-used device that directly supports patient care
- Join a small R&D team with real electrical design ownership, not a support-only role
- Broad technical scope across PCB design, power systems, embedded interfaces, and RF integration
- Individual contributor role with visibility into the full regulated product lifecycle
- 10% bonus eligibility, employee flexibility, and investment in career development