Director of Embedded Software & Systems (Regulated)

Hobbsnews; Irvine (CA); On-site; USD 179,000 - 323,000; Full time

Job summary

Becton, Dickinson, and Company (BD) Irvine, CA seeks a Director of Embedded Software Development to lead strategy, architecture, and regulatory compliance for firmware across medical devices. You will mentor teams, drive RTOS-based systems, and ensure safety, security, and reliability from concept to manufacturing.

Responsibilities include defining a technical vision, guiding design, collaborating with hardware and clinical teams, and overseeing regulatory submissions and risk management.

Qualifications

• Bachelor’s degree in Engineering or equivalent medical device leadership experience.
• 10+ years in embedded software, ideally in regulated environments.
• 8+ years in engineering management leading teams.
• Strong C/C++ in Linux/RTOS, with microcontrollers and drivers.
• Deep IEC 62304, ISO 14971, and FDA software validation knowledge.
• Travel to vendors/customers as needed; CI/CD and cybersecurity focus.
• Proven ability to work with external vendors and partners.

Responsibilities

• Define the embedded software vision, roadmap, and architecture for medical devices.
• Recruit, mentor, and retain engineering talent; foster collaboration.
• Ensure regulatory compliance with documentation for submissions.
• Guide embedded design (C/C++) and hardware interfaces (SPI, I2C, UART, USB, Ethernet).
• Collaborate with hardware, applications, product, and clinical teams.
• Address cybersecurity risk modeling and safety-critical development.
• Manage schedules, budgets, and resources across projects with agile methods.

Skills

C/C++

RTOS

Linux

Regulatory standards

Cybersecurity

Leadership

Team management

Communication

Vendors collaboration

Embedded systems architecture

Education

Bachelor’s degree in Engineering

Tools

CI/CD pipelines

Microcontrollers

Low-level drivers

Job description

Becton, Dickinson, and Company (BD) Irvine, CA seeks a Director of Embedded Software Development to lead strategy, architecture, and regulatory compliance for firmware across medical devices. You will mentor teams, drive RTOS-based systems, and ensure safety, security, and reliability from concept to manufacturing.

Responsibilities include defining a technical vision, guiding design, collaborating with hardware and clinical teams, and overseeing regulatory submissions and risk management.