Engineering Manager

Purpose

The Engineering Manager (Firmware & Hardware) is 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 Quality Management System (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.

2 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.

3 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 rehab 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 resolution integrated with ISO 14971 risk management.

Coordinate with internal or external security and privacy resources so firmware, communication paths, and logs reflect appropriate cybersecurity and patient privacy considerations, consistent with UGen policies and relevant standards.

Maintain traceability from requirements architecture implementation tests risk controls so CAPA actions and complaint investigations can be tied to specific design and code elements.

Partner with Quality/Regulatory and Manufacturing (complaints, CAPA, post-market, production readiness)

Partner with QARA to keep firmware/hardware changes risk-based, controlled, and inspection-ready.

Provide technical leadership for device-related complaints, nonconformances, and CAPAs: problem framing, root-cause hypotheses, assessment of design/firmware contributions, and technical remediation plans.

Support CAPA verification of effectiveness by defining and executing appropriate engineering tests.

Partner with Manufacturing to define build, calibration, and test procedures for sensors and kits, and bake design-for-manufacturability and design-for-serviceability into engineering decisions.

Lead or support structured root cause analysis for device-related issues in the lab and in the field, ensuring:

Corrective actions are implemented in firmware, hardware, and/or design and appropriately documented.

Preventive actions (design changes, test improvements, process updates) are integrated into the roadmap and the QMS.

4 Must-Have Qualifications

Strong alignment with the majority following:

10+ years in engineering roles, with recent, hands-on firmware/embedded experience (C/C++, RTOS, microcontrollers, sensor integration, low-level data processing, and device communication).

5+ years leading engineering teams or major multi-disciplinary device programs (firmware/hardware/systems).

Demonstrated experience shipping connected devices (wearables, IoT, or medical/health devices) that integrate with apps and cloud services.

Practical experience working within an ISO 13485-compliant or aligned QMS, particularly in design/development and post-market / CAPA-related activities.

Practical experience with an IEC 62304-aligned lifecycle for device software/firmware (classification, risk integration, maintenance).

Track record contributing to or leading technical aspects of complaints, nonconformances, and CAPAs (root cause analysis, engineering changes, verification evidence for technical actions).

Proven ability to translate clinical/product needs into concrete engineering requirements, tradeoffs, and implementation plans.

Comfort owning code and leading people: ability to write production quality firmware and coach a small, multidisciplinary team.

Experience with modern tooling for firmware and systems development (version control, code review workflows, automated build/test where appropriate, issue tracking and documentation that support traceability).

Bachelor s degree in Electrical Engineering, Computer Engineering, Software Engineering, Mechanical Engineering, Biomedical Engineering, Physics, or equivalent practical experience.

5 Nice-to-Have Experience

Familiarity with ISO 14971 risk management and IEC 62366-1 usability engineering.

Prior involvement in design transfer to manufacturing, including fixtures and end-of-line test strategies.

Experience in rehabilitation, orthopedics, sports medicine, or digital therapeutics.

Experience building or maturing engineering functions in early- to growth-stage startups.

Master s degree or PhD.

PMP.

CQA (particularly helpful for engineers who enjoy working fluently in regulated environments).

6 What Success Looks Like in Year One

A successful Engineering Manager (Firmware & Hardware) will have:

Established clear firmware and hardware ownership within the team, rather than it being spread across the Founder and consultants.

Designed and implemented a fit-for-purpose lifecycle for device/firmware work that fits into the ISO 13485-aligned QMS and aligns with IEC 62304 expectations.

Led at least one major rehab pathway or feature from clinical/product needs device requirements device implementation (including direct contributions) V&V release, with clean integration to apps and backend.

Enhance systems established to reduce surprises while maintaining appropriate safety, data integrity, cybersecurity, and security safeguards.

Put in place a systematic and scalable approach so device issues from complaints, nonconformances, and internal/external testing are reliably captured, analyzed, addressed with well-scoped corrective and preventive actions, and verified for effectiveness which feed lessons back into design, testing, and manufacturing.

7 Who Will Be Most Successful in This Role

This role is a strong fit for someone who:

Enjoys owning the device stack end-to-end (sensors, firmware, hardware, and system integration with software).

Likes balancing hands-on firmware work, technical leadership, and post-market problem solving (complaints, nonconformances, CAPAs).

Can bridge clinical reality and engineering pragmatism by listening carefully and translating needs into safe, buildable, maintainable device behavior.

Values standards-driven, risk-managed development and sees quality/regulatory rigor and appropriate security/privacy controls as part of strong engineering.

Is comfortable in an early-stage environment where building teams, processes, CAPA pathways, and tooling is part of the charter.

Communicates clearly across engineering, product, quality/regulatory, manufacturing, clinical, and commercial functions.