Staff Firmware Engineer

R2 Global; Trumbull (CT); On-site; USD 140,000 - 180,000; Full time

Job summary

R2 Global is seeking a Staff Firmware Engineer to architect, develop, and verify embedded firmware for advanced medical devices. You will lead cross-functional teams across hardware, software, quality, and regulatory functions in a fast-paced NPD environment.

The role focuses on independent work, guiding architecture and development strategy while ensuring compliance with medical device standards and design controls.

Qualifications

• Minimum 7 years firmware development experience in complex embedded/electronic systems.
• Experience with medical devices or other regulated embedded products.
• Strong understanding of firmware architectures and development methodologies.
• Proven ability to lead development activities across multiple projects.

Responsibilities

• Define firmware architectures for complex embedded systems.
• Lead firmware design, coding, integration and testing for electromechanical medical devices.
• Collaborate with hardware teams to optimize system architecture and performance.
• Develop and execute verification/validation strategies for firmware systems.
• Mentor firmware engineers and drive software development standards.

Skills

Firmware development

Embedded systems

Leadership

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Electrical/Computer/Mechatronics

Master's degree desirable

Tools

C/C++

ARM Cortex‑M

RTOS (FreeRTOS/Zephyr/Embedded Linux)

Altium Designer

Hardware debugging tools

Job description

Our client is an innovative medical technology organization focused on developing advanced healthcare solutions that improve patient outcomes around the world. Their multidisciplinary R&D teams work across connected medical technologies, electromechanical systems, and next-generation healthcare devices, bringing innovative products from concept through commercialization.

This role offers the opportunity to participate in the complete product development lifecycle, contributing to innovative technologies from early-stage concept development and feasibility assessment through rigorous engineering, verification, validation, and successful market launch.

Position Overview

The Staff Firmware Engineer is a senior technical specialist responsible for the architecture, design, development, and verification of embedded firmware and electronic systems supporting complex medical device programs.

Working within a New Product Development environment, this role will lead firmware development efforts for sophisticated electromechanical and connected systems. The successful candidate will have ownership of significant technical workstreams, providing technical leadership while collaborating closely with cross-functional engineering, quality, regulatory, manufacturing, and project teams.

This position requires an experienced engineer capable of working independently with limited supervision while influencing product architecture, technical direction, and development strategy across multiple projects.

Key Responsibilities

• Define and implement firmware architectures for complex embedded systems.
• Lead firmware design, coding, integration, and testing activities for electromechanical medical devices.
• Collaborate closely with hardware teams to influence system architecture and optimize performance.
• Analyze system behavior and conduct simulations to understand critical performance parameters and sensitivities.
• Establish design feasibility through hardware and firmware testing, including statistical performance evaluation of critical functions.

Design Controls & Regulatory Compliance

• Ensure compliance with medical device software development standards and design control requirements.
• Support and oversee the development of product requirements, design inputs, and technical specifications.
• Drive software lifecycle processes in accordance with IEC 62304 and other applicable medical device regulations and standards.
• Develop and execute verification and validation strategies for firmware systems.
• Create verification test protocols, perform testing, and generate detailed verification reports.

Electronics & Embedded Systems Development

• Design, troubleshoot, and optimize firmware and associated electronic systems.
• Support hardware debugging and system integration activities.
• Collaborate on electronic circuit design and review activities.
• Develop and implement embedded control systems for real-world product applications.
• Assist with prototyping, proof-of-concept development, and technical feasibility studies.

Technical Leadership

• Provide mentorship and technical guidance to firmware engineers, junior engineers, and interns.
• Promote engineering best practices and software development standards throughout the organization.
• Support project planning, scheduling, and technical decision-making activities.
• Lead technical discussions and reviews with both internal stakeholders and external development partners.
• Influence engineering policies, procedures, and development methodologies across the wider R&D organization.

Cross-Functional Collaboration

• Work closely with multidisciplinary teams to ensure projects are delivered on schedule and aligned with business objectives.
• Coordinate activities with quality, regulatory, manufacturing, and systems engineering teams.
• Manage relationships with external suppliers, consultants, and development partners.
• Communicate technical information effectively to stakeholders ranging from engineers and project managers to senior leadership.

Required Qualifications

• Extensive experience developing firmware for medical devices or other highly regulated embedded systems.
• Strong understanding of embedded software architecture and firmware development methodologies.
• Proven ability to lead technical development activities across complex engineering projects.
• Experience integrating firmware with sophisticated electromechanical, mechatronic, robotic, or connected systems.

Embedded Software Development

• Strong hands‑on programming experience in C and C++.
• Experience designing and implementing state machines.
• Strong understanding of embedded system architectures, including both bare‑metal and real‑time operating systems.
• Experience with RTOS platforms such as FreeRTOS, Zephyr, Embedded Linux, or similar environments.
• Practical experience implementing control algorithms including PID controllers and digital filtering techniques.

Microcontrollers & Communications

• Working knowledge of ARM Cortex‑M microcontrollers and their associated peripherals.
• Experience with communication interfaces including:
• USB
• SPI
• I2C
• UART
• GPIO
• CAN Bus

Electronics & Hardware Integration

• Solid understanding of:
• Signal conditioning
• Filters
• Digital electronics
• Experience with hardware/software integration and system‑level debugging.
• Hands‑on experience using laboratory instruments and diagnostic equipment.
• Familiarity with schematic capture and PCB design tools such as Altium Designer.

Medical Device Development

• Strong understanding of Design Control and regulated product development requirements.
• Knowledge of FDA, MDR, ISO, and other applicable medical device standards.
• Experience translating User Needs into Design Inputs and Verification requirements.
• Proven experience creating and executing firmware verification protocols and technical reports.

Additional Skills

• Experience managing technical programs, development partners, or multidisciplinary engineering initiatives.
• Knowledge of statistical methods and Design of Experiments (DOE).
• Hands‑on technical aptitude including prototyping, soldering, troubleshooting, and system assembly.
• Strong project execution, problem-solving, and analytical skills.
• Excellent communication and stakeholder management capabilities.

Experience

• Minimum of 7 years of firmware development experience supporting complex embedded or electrical systems.
• Previous experience within the medical device industry is strongly preferred.
• Demonstrated technical leadership experience across product development programs.
• Experience working in multidisciplinary engineering environments delivering regulated products.

Education

• Bachelor's degree in Computer Science, Electrical Engineering, Electronics Engineering, Computer Engineering, Robotics, Mechatronics, or a related technical discipline.
• Master's degree or other advanced technical qualifications are highly desirable.

This is primarily an on-site engineering position involving a combination of office and laboratory activities. The role includes working with electronic and mechanical test equipment, embedded systems development tools, and prototype hardware. Occasional travel may be required for supplier visits, technical meetings, training programs, and industry events. Extended periods of computer-based work and hands‑on laboratory testing should be expected.