Description

Required Qualifications:

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline.
• Typically 10–15+ years of professional embedded software or firmware development experience.
• Demonstrated experience operating at Principal Engineer, Senior Staff Engineer, Software Architect, or equivalent technical-leadership level.
• Strong hands-on experience developing embedded software in C and/or C++.
• Experience developing software for regulated medical devices, IVD systems, healthcare products, or another safety-critical regulated industry.
• Experience with the complete embedded software lifecycle, including requirements, architecture, design, implementation, integration, verification, release, and maintenance.
• Strong understanding of embedded-system architecture and hardware-software interaction.
• Experience debugging complex embedded systems using appropriate hardware and software tools.
• Experience developing and maintaining multithreaded, real-time, or event-driven embedded applications.
• Experience with embedded operating systems, embedded Linux, or real-time operating systems.
• Experience with device drivers, hardware abstraction, communication interfaces, and peripheral integration.
• Strong understanding of software architecture, modular design, state machines, memory management, concurrency, and fault handling.
• Experience with source control, configuration management, code reviews, defect tracking, and controlled software releases.
• Ability to analyze and improve large or legacy embedded codebases.
• Experience producing high-quality technical and software lifecycle documentation.
• Strong analytical, troubleshooting, and root-cause-analysis skills.
• Ability to lead technical work through influence without direct management authority.
• Excellent written and verbal English communication skills.

Embedded Technical Skills:

• Advanced C and/or C++ development.
• Embedded Linux and/or RTOS development.
• Multithreaded and real-time software design.
• Low-level firmware and device-driver development.
• Hardware abstraction layer design.
• Board bring-up and hardware-software integration.
• Inter-process communication and event-driven architectures.
• Serial and hardware communication protocols such as UART, SPI, I²C, USB, CAN, or Ethernet.
• Network communication and device-connectivity protocols.
• Memory, performance, timing, and resource optimization.
• Error handling, fault detection, diagnostics, logging, and recovery mechanisms.
• Unit testing, integration testing, static analysis, and code-coverage analysis.
• Debugging tools such as JTAG, oscilloscopes, logic analyzers, protocol analyzers, and embedded debuggers.
• Build systems, cross-compilation toolchains, and CI/CD pipelines.
• Secure coding and embedded cybersecurity principles.

Medical-Device Responsibilities:

• Develop software in compliance with applicable quality-system procedures.
• Ensure that embedded software development follows IEC 62304 lifecycle processes.
• Support software safety classification and risk-based development activities.
• Contribute to hazard analysis and software-related risk assessment.
• Implement and document software risk-control measures.
• Maintain traceability between requirements, risks, architecture, implementation, and verification.
• Produce or review software development plans, requirements, architecture, detailed designs, test documentation, anomaly assessments, and release records.
• Support Design History File creation and remediation.
• Participate in formal design reviews.
• Ensure unresolved software anomalies are properly evaluated and documented.
• Support software validation, regulatory submissions, audits, and inspections.
• Contribute to cybersecurity threat analysis, vulnerability assessment, and remediation

Key Skills

Education

Bachelor's or Master's degrees