Full Job Description
The Director of Embedded Software Development is a senior leadership role responsible for the strategy, architecture, development, and regulatory compliance of firmware and embedded software. This role demands a blend of deep technical expertise in real-time systems, hands-on leadership, and experience with applicable regulatory compliance standards.
This individual will lead, mentor, and scale embedded software/firmware engineering teams, ensuring that the software is safe, secure, and reliable. The position requires bridging the gap between hardware, software, and systems engineering to deliver high-quality products from concept to manufacturing through sustaining.
Responsibilities:
• Strategic Leadership: Define and execute the embedded software engineering vision, roadmap, and technical architecture for the medical device product portfolio.
• Team Management & Development: Recruit, mentor, and retain top-tier talent, fostering a culture of innovation, excellence, and collaboration.
• Regulatory Compliance & Quality: Ensure compliance with regulatory standards, overseeing the creation of documentation for regulatory submissions as required.
• Technical Oversight & Architecture: Guide the embedded design (C/C++), including RTOS-based applications, control algorithm integrations, and hardware interfaces (SPI, I2C, UART, USB, Ethernet, etc.).
• Support technology innovation and clinical data collection projects as required in conjunction with internal teams.
• Cross-Functional Collaboration: Partner with hardware, applications, product management, and clinical teams as required to optimize system performance and meet user needs.
• Risk & Cybersecurity: Contribute to cybersecurity threat modeling and risk management for medical devices in conjunction with cybersecurity teams.
• Project Management: Manage schedules, budgets, and resources across multiple projects, utilizing agile methodologies.
Qualifications:
• Education: Bachelor's degree in an Engineering discipline preferred, or equivalent medical device development and leadership experience.
• Experience: 10+ years in embedded software development, with significant experience in regulated industry environments, preferably medical devices.
• Leadership: 8+ years of experience in an engineering management role, leading engineering and technical teams.
• Technical Skills: Strong proficiency in C/C++ in a Linux/RTOS environment, as well as microcontrollers and low-level drivers.
• Regulatory Knowledge: Deep understanding of IEC 62304, ISO 14971, and FDA software development and validation requirements.
• Occasional travel to vendors and customer sites may be required on an as needed basis.
• Experience with CI/CD Build Pipelines and target testing methodologies for medical devices.
• Expertise in cybersecurity protocols and safety-critical system development.
• Proven ability to work with external vendors and partners as required.
• Excellent communication skills, with the ability to convey technical concepts to non-technical stakeholders.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. We require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.
Primary Work Location
USA CA - Irvine Laguna Canyon
Salary Range Information
$179,200.00 - $322,500.00 USD Annual
