Engineering Manager

Overview

The Engineering Manager (Firmware & Hardware) is UGen’s device-side engineering leader. This role owns firmware and hardware responsibilities end-to-end, including hands‑on firmware development, and is accountable for how the device stack behaves in real‑world use.

You will operate within an ISO 13485‑aligned QMS and an IEC 62304‑aligned device software/firmware lifecycle. You will be a core technical partner in complaint investigations, nonconformance handling, and CAPA execution for device‑related issues, and you will share accountability alongside Product and Quality/Regulatory for device‑side safety, reliability, cybersecurity, and data integrity.

This role works closely with the VP of Product (who owns the apps, cloud software, and software engineering team) and with the Founder on deep technical architecture decisions. It is a leadership‑and‑execution role: building the function, writing and reviewing code, and maintaining a state of inspection readiness through disciplined design controls, documentation, and traceability.

Accountabilities

You are accountable for:

• Firmware/embedded software on the sensors
• Sensor hardware and electronics, including device‑side systems engineering
• The firmware and hardware engineering team(s) and their execution processes
• Device‑side technical leadership and deliverables for complaints, nonconformances, and CAPAs (root cause hypotheses, remediation plans, and verification evidence), in coordination with QARA
• System‑level integration interfaces and coordinated releases with the software team
• Device performance and diagnosability in real‑world use, including reducing integration surprises and enabling effective root‑cause analysis over time

Key Responsibilities Build and lead the Firmware & Hardware Function

• Build and lead a small but growing team of firmware, hardware, and systems engineers, supported by key consultants as needed
• Build sustainable in‑house engineering capability over time (people, process, tooling, and execution cadence)

Translate clinical and product needs into actionable engineering work

• Collaborate with clinical, product, and commercial stakeholders to understand real rehabilitation workflows, constraints, and desired outcomes
• Turn those needs into clear, testable device/firmware requirements, interface contracts, and implementation plans
• Define pragmatic acceptance criteria and test strategies so clinical requirements map to specific, verifiable device behaviors

Write and review firmware (and system‑level) code

• Spend a meaningful portion of time writing and reviewing production firmware, primarily across embedded C/C++, RTOS, sensor drivers, connectivity, and data processing
• Contribute to system‑level software where device integration is critical (e.g., SDKs, device communication layers, ingest paths), in partnership with the software team
• Reinforce engineering practices suitable for embedded systems, including:
• Version control and structured code review
• Automated build and test pipelines where practical
• Issue tracking and documentation that support traceability and effective root‑cause analysis
• Raise the bar on coding standards, testing discipline, and documentation so design and code remain understandable, maintainable, and diagnosable over time

Drive device‑side execution and integration

• Own the firmware and hardware roadmap, aligning it with product priorities, safety/risk considerations, and manufacturing/supply constraints
• Plan and coordinate releases so device changes align cleanly with app and backend expectations (versions, data contracts, and observable behavior)
• Ensure device‑side changes driven by CAPAs, field issues, or nonconformances are scoped, prioritized, implemented, and verified in a structured way

Implement practical, compliant processes (ISO 13485 and IEC 62304)

• Work within the ISO 13485‑aligned QMS so device engineering supports design and development controls (requirements, design reviews, V&V, design transfer, and design changes)
• Help ensure device firmware follows an IEC 62304‑aligned lifecycle, including planning/classification, requirements, architecture, implementation, integration/testing, and maintenance/problem…