POSITION SUMMARY:

The Principal Firmware Engineer is a technical leader responsible for the architecture, design, development, verification, and lifecycle management of embedded firmware for In Vitro Diagnostic (IVD) medical devices developed under an ISO 13485-compliant Quality Management System.

This role ensures firmware is developed in accordance with applicable regulatory requirements including IEC 62304 (Medical Device Software Lifecycle), ISO 14971 (Risk Management), and EU IVDR (2017/746) as applicable. The Principal Firmware Engineer provides architectural leadership, ensures full design control compliance, maintains requirements traceability, and supports regulatory submissions and post-market obligations.

The position partners cross-functionally with Systems Engineering, Electrical Engineering, Mechanical Engineering, Quality, Regulatory Affairs, Manufacturing, and external clients to deliver robust, production-ready firmware that meets safety, performance, and reliability requirements for IVD instrumentation.

ESSENTIAL FUNCTIONS (Primary Responsibilities):

These may include, but are not limited to:

1. Firmware Architecture & Technical Leadership

• Defines and owns firmware architecture for embedded IVD instrumentation platforms.
• Ensures architecture supports safety classification and software safety class determination per IEC 62304.
• Establishes reusable firmware frameworks aligned with regulatory compliance and traceability requirements.
• Conducts and leads formal design reviews in accordance with ISO 13485 design control procedures.
• Evaluates technical risks and implements mitigation strategies consistent with ISO 14971 risk management files.

2. Design Controls & Regulatory Compliance

• Authors and reviews software/firmware requirements specifications (SRS), architecture documents, detailed design documents, and traceability matrices.
• Ensures bidirectional traceability from system requirements through firmware requirements, implementation, verification, and validation.
• Supports hazard analysis, FMEA, fault tree analysis, and cybersecurity risk assessments.
• Contributes to DHF (Design History File) documentation.
• Ensures firmware development activities align with:
• IEC 62304 (software lifecycle processes)
• ISO 14971 (risk management)
• ISO 13485 (design controls and documentation)
• EU IVDR 2017/746 requirements (as applicable)
• Supports internal and external audits (Notified Body, FDA, client audits).

3. Embedded Firmware Development

• Designs, develops, and debugs embedded firmware (primarily C/C++) for MCU- and MPU-based IVD platforms.
• Implements real-time firmware using RTOS or embedded Linux environments.
• Develops device drivers and low-level interfaces (SPI, I2C, UART, CAN, USB, Ethernet).
• Performs hardware bring-up, board-level debugging, and system integration.
• Implements secure boot, firmware update mechanisms, and cybersecurity controls appropriate for medical devices.
• Performs root cause analysis of firmware defects and field issues; documents corrective actions per QMS procedures.

4. Verification, Validation & Test

• Defines and reviews firmware verification strategies including:
• Unit testing
• Integration testing
• System-level testing
• Regression testing
• Ensures objective evidence is generated and retained per ISO 13485 requirements.
• Supports validation activities including clinical or performance validation where firmware functionality impacts diagnostic output.
• Assists in development of production test software and manufacturing validation.
• Reviews and approves verification protocols and reports.

5. Cross-Functional & Client Collaboration

• Collaborates with Systems Engineering to translate assay, instrument, and workflow requirements into firmware specifications.
• Partners with Electrical Engineering to review schematics and ensure hardware/firmware compatibility and reliability.
• Interfaces with Quality and Regulatory Affairs to support submissions and technical documentation.
• Provides technical leadership during design transfer to Manufacturing.
• Supports post-market surveillance activities, complaint investigations, and field corrective actions involving firmware.

6. Mentorship & Process Improvement

• Mentors firmware and software engineers in regulated development practices.
• Drives continuous improvement of firmware development processes within the ISO 13485 framework.
• Promotes secure coding practices, documentation rigor, and risk-based thinking.
• Serves as subject matter expert for embedded systems in IVD environments.

The functions/responsibilities outlined in this Job Description have an impact to the QMS and product quality.

EDUCATION, EXPERIENCE, SKILLS AND ABILITIES REQUIRED:

Education & Experience

• Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Computer Science, or related field.
• Typically, 10+ years of embedded firmware development experience.
• Minimum 5+ years developing firmware within a regulated medical device environment.
• Demonstrated experience with IVD instrumentation or diagnostic platforms strongly preferred.

Essential Knowledge, Skills & Abilities

Regulatory & Quality Systems

• Strong working knowledge of:
• ISO 13485 design controls
• IEC 62304 software lifecycle processes
• ISO 14971 risk management
• EU IVDR 2017/746 requirements
• Experience contributing to DHF documentation and technical files.
• Experience supporting internal and external regulatory audits.
• Strong understanding of requirements, traceability and change control.

Embedded Systems Expertise

• Expert-level C/C++ development for embedded systems.
• Strong experience with ARM Cortex architectures or similar.
• Experience with RTOS (e.g., FreeRTOS, ThreadX) or embedded Linux.
• Deep understanding of communication protocols: SPI, I2C, UART, CAN, USB, TCP/IP, Ethernet.
• Experience with hardware/firmware integration and low-level debugging.
• Knowledge of secure firmware practices and medical device cybersecurity considerations.

Verification & Risk-Based Development

• Strong understanding of risk-based software classification.
• Experience implementing unit test frameworks and automated testing.
• Familiarity with static analysis tools and coding standards (e.g., MISRA C where applicable).
• Ability to connect firmware design decisions to system-level risk mitigations.

Tools & Technologies

• Experience with embedded IDEs (e.g., STM32CubeIDE, IAR, Keil).
• Experience with version control and configuration management (Git or equivalent).
• Familiarity with scripting (Python or similar) for test automation.
• Experience using debugging tools such as JTAG/SWD, oscilloscopes, and logic analyzers.

Leadership & Communication

• Excellent written and verbal communication skills.
• Ability to clearly document complex technical concepts for regulatory review.
• Strong client-facing technical leadership experience.
• Proven mentoring and technical leadership capabilities.
• High attention to detail and commitment to product safety and quality.

EFFORT REQUIRED:

Physical Activities: On a continuous basis, sit at desk for a long period of time; write or use a keyboard to communicate through written and oral means. Intermittently answer telephone. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

TRAVEL:

This position may require some travel (domestic and international).