Sibel Health · 3 weeks ago
Manager of Firmware Development
Sibel Health is an award-winning digital health startup focused on delivering better health data for vulnerable patients. They are seeking a Manager of Firmware Development to lead a team of embedded software engineers and ensure robust firmware development processes that comply with regulatory standards.
Artificial Intelligence (AI)Health CareMedicalMedical Device
Responsibilities
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
Qualification
Required
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
Preferred
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.
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.
Company
Sibel Health
Sibel Health is a medical technology company that provides wireless vital signs monitoring and data integration.
H1B Sponsorship
Sibel Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (8)
2023 (3)
Funding
Current Stage
Growth StageTotal Funding
$92.26MKey Investors
U.S. Food and Drug AdministrationSteele Foundation for HopeBill & Melinda Gates Foundation
2025-12-09Grant· $0.5M
2025-09-30Series C· $9M
2025-03-20Series C· $30M
Recent News
vcnewsdaily.com
2025-10-15
2025-10-15
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