Director, Embedded Software Development

BD Mexico; Irvine (CA); Hybrid; USD 179,200 - 322,500; Full time

Job summary

BD Mexico is seeking a Senior Manager of Embedded Software Engineering in Irvine, California. This role requires a strategic leader to oversee the embedded software development for medical devices. You'll manage and develop teams, ensure regulatory compliance, and collaborate with cross-functional teams to optimize system performance. Experience in embedded software and leadership is essential, along with proficiency in C/C++ and regulatory standards. The position includes a hybrid work model with a minimum in-office requirement of 4 days a week.

Qualifications

• 10+ years in embedded software development within regulated industries.
• 8+ years of leadership experience in an engineering management role.
• Deep understanding of IEC 62304, ISO 14971, FDA requirements.

Responsibilities

• Define and execute the embedded software engineering vision.
• Recruit, mentor, and retain top-tier talent.
• Ensure compliance with regulatory standards.

Skills

Embedded software development

C/C++ proficiency

Leadership experience

Regulatory compliance knowledge

Cybersecurity protocols expertise

Education

Bachelor's degree in Engineering or equivalent experience

Tools

Linux/RTOS environment

CI/CD Build Pipelines

Job description

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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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.

Salary Range

$179,200.00 – $322,500.00 USD Annual

EEO Statement

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.