Role: Embedded software Engineer Design Controls Remediation
Location: Remote (EST)

Summary:
Mid-to-senior level (5 8+ yrs). Specializes in firmware and embedded software design controls - gap assessments and remediation across Design Inputs, Outputs, V&V, and Risk Management. Requires hands-on embedded/firmware experience in a regulated environment.

Key Responsibilities

• Assess and remediate embedded SW requirements, code architecture, and design documentation
• Conduct embedded-specific risk and failure mode analyses
• Develop or update unit/integration verification protocols and traceability
• Identify cybersecurity and real-time performance gaps in embedded design outputs
• Ensure SW lifecycle documentation aligns with Design Transfer readiness

Required Qualifications

• Degree in Electrical Engineering, Software Engineering, or related field
• Medical device embedded SW development experience under IEC 62304
• Proficiency with RTOS, C/C++, and embedded debugging tools
• Experience with embedded SW risk management and V&V in regulated environments
• Knowledge of FDA cybersecurity requirements for embedded systems

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