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REQ Solutions · 22 hours ago

Firmware Engineer

Irvine, CA

Contract

Hybrid

Mid, Senior Level

$60/hr - $62/hr

4+ years exp

REQ Solutions is seeking a Firmware Engineer to contribute to the development of embedded systems for medical devices. The role involves firmware architecture, development, and compliance with regulatory standards, while collaborating with cross-functional teams to ensure successful product integration and testing.

Outsourcing/Offshoring

Hiring Manager

Deep Shah

Responsibilities

Strong technical expertise in C and C# development, along with a solid understanding of medical device embedded systems and system integration

Participate in technology evaluations, technical specification development, technical assessments and validation of firmware architectures, embedded software, and system integration aspects of active implantable medical devices

Support the firmware specification development, firmware architecture, embedded firmware development, and integration for active implantable medical devices

Ensure that firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971and other regulatory standards governing medical device firmware

Maintain thorough design documentation, traceability matrices, and software development lifecycle (SDLC) artifacts for regulatory submissions

Participate in software and system risk management activities throughout the SDLC

Participate in testing strategies (Unit/Integration) and design verification protocols to verify firmware functionality

Provide technical inputs on low-power embedded systems and wireless communication (e.g., BLE, NFC, RF telemetry)

Establish and document firmware development lifecycle (SDLC) artifacts and processes to align with internal quality management systems (QMS)

Perform firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments

Collaborate with regulatory teams on 510(k), PMA, or CE Mark submissions involving firmware-related changes

Contribute to the process of transferring the product from development to manufacturing

Qualification

C programmingC# programmingEmbedded systemsFirmware developmentRegulatory complianceRisk assessmentTestingDebuggingLow-power embedded systemsMicrosoft Visual StudioProject managementCommunication skills

Required

Strong technical expertise in C and C# development, along with a solid understanding of medical device embedded systems and system integration

Support the firmware specification development, firmware architecture, embedded firmware development, and integration for active implantable medical devices

Ensure that firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971 and other regulatory standards governing medical device firmware