A BIT ABOUT SIBEL HEALTH:

With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we’ve launched our technologies in 20 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations in the world from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

THE OPPORTUNITY:

We are seeking a results-oriented Manager of Firmware Development to lead a high-performing team of embedded software engineers. This role is critical to not only driving technical innovation but also developing and enforcing robust firmware development processes, ensuring governance, traceability, and regulatory compliance throughout the product lifecycle.

This individual will play a central role in shaping the infrastructure, policies, and tools that support scalable, high-quality firmware development in alignment with FDA and global regulatory standards.

WHAT YOU WILL BE WORKING ON:

• Lead, mentor, and grow a team of firmware engineers responsible for embedded system development across multiple product lines.
• Develop, implement, and maintain firmware development processes that meet regulatory and internal quality system requirements.
• Establish governance structures for code reviews, design documentation, change control, and risk management.
• Oversee firmware architecture, design, implementation, and integration for embedded systems in medical devices.
• Ensure alignment with standards such as IEC 62304, ISO 13485, and FDA 21 CFR Part 820.
• Drive the selection and implementation of tools for version control, continuous integration, and test automation.
• Collaborate cross-functionally with hardware, systems, quality, regulatory, and manufacturing teams.
• Manage engineering resources and deliverables across multiple concurrent development efforts.
• Identify and mitigate technical and process-related risks proactively.
• Serve as a champion for continuous improvement in firmware development and lifecycle management.

ABOUT YOU:

• Bachelor’s degree in Electrical, Computer, Software Engineering, or Biomedical Engineering.
• 7+ years of experience in embedded firmware development, including 3+ years in a technical leadership or management role.
• Deep understanding of embedded systems design, firmware development processes, and quality governance.
• Demonstrated experience in defining and improving engineering processes in a regulated environment.
• Strong knowledge of C/C++ and RTOS for embedded microcontrollers.
• Track record of successful product development in a heavily regulated industry, including familiarity with design controls and risk management.
• Excellent leadership, communication, and collaboration skills.
• Experience in wireless protocols (e.g., BLE, Wi-Fi) and Connectivity for medical devices.

YOU MAY THRIVE IN THIS ROLE IF:

• Direct experience in Medical Device Engineering and Medical Device Manufacturing.
• Hands-on experience with Jira and Git, or similar tools, for lifecycle management.
• Working knowledge of safety standards such as ISO 14971, IEC 60601, or ISO 27001.
• Understanding of Agile methodologies and their use in medical device manufacturing.

BENEFITS:

• Competitive salary and comprehensive benefits package.
• A leadership role in an innovative and purpose-driven organization.
• Medical, dental, vision, life, and disability insurance.
• "Take as much time as you need" policy.
• Simple IRA plan with employer matching.
• Stipend for professional development.
• Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring.
• A culture that prioritizes quality, safety, and personal growth.
• Opportunities to influence and shape the future of medical technology.