Engineering Manager

The Engineering Manager (Firmware & Hardware) is the device-side technical leader responsible for end-to-end ownership of firmware, embedded software, and sensor hardware for connected medical devices. This role combines hands‑on firmware development with engineering leadership to ensure devices are safe, reliable, diagnosable, and inspection‑ready in real-world clinical use.

You will lead a growing firmware and hardware team, contribute directly to production firmware (C/C++, RTOS), and operate within an ISO 13485-aligned QMS and IEC 62304-aligned software lifecycle
. The role partners closely with Product, Quality/Regulatory, Manufacturing, and Software to deliver compliant, well‑integrated device releases and to lead device‑related complaint investigations, nonconformances, and CAPAs.

• Own firmware, embedded software, and device hardware end‑to‑end
• Build and lead a small firmware/hardware engineering team
• Write and review production firmware and system‑level code
• Translate clinical and product needs into clear, testable device requirements
• Lead device‑side execution for complaints, nonconformances, and CAPAs
• Ensure compliant design controls, traceability, and inspection readiness

• 10+ years of engineering experience with hands‑on embedded/firmware development
• 5+ years leading engineering teams or device programs
• Experience shipping connected medical, wearable, or IoT devices
• Working knowledge of ISO 13485 and IEC 62304
• Strong ability to balance hands‑on coding, technical leadership, and cross‑functional collaboration

Mid‑Senior level

Full‑time

Manufacturing

Akron, OH

$/yr - $/yr