Staff Embedded Software Engineer (Onsite)

We are seeking a Staff Embedded Software Engineer to lead the design, development, and documentation of embedded software for medical devices. In this role, you will be responsible for delivering high-quality, reliable, and compliant software solutions while adhering to internal software development lifecycle processes and FDA software development guidance.

In addition to product software development, you will partner with multidisciplinary teams to design and develop software for manufacturing fixtures and provisioning systems that support product configuration, testing, and in-line manufacturing processes. This role requires strong expertise in embedded systems, excellent problem-solving skills, and the ability to influence technical direction while delivering solutions that enhance product quality, reliability, and operational efficiency.

What You Will Do

• Design and develop embedded software and supporting documentation for medical devices in accordance with internal software development lifecycle processes and FDA software development guidance.

• Collaborate with cross-functional teams, including R&D, Systems Engineering, Quality, Manufacturing, Regulatory Affairs, and Advanced Operations, to ensure effective communication and successful product development.

• Support legacy products through root-cause investigation, defect resolution, and continuous improvement initiatives.

• Partner with multidisciplinary teams to plan and execute software verification and validation activities.

• Conduct advanced problem solving, identify potential solutions, and evaluate them against system and sub-system requirements.

• Collaborate with Advanced Operations, Manufacturing, and third-party suppliers to develop and review manufacturing fixture software and ensure deliverables meet quality and software documentation standards.

What You Need (Minimum Required Qualifications)

• Bachelor's degree in Software Engineering, Computer Science or related discipline

• 4+ years of professional work experience

• Experience in C/C++ software development for embedded systems.

• Hands-on experience with Python development, including scripting, automation, and application development.

Preferred Qualifications (Strongly Desired)

• Experience developing embedded software using C/C++ on bare-metal and/or RTOS-based embedded platforms.

• Strong experience in Python programming, including design, development, testing, and maintenance of software applications.

  Experience driving adoption of software lifecycle management and requirements traceability tools and processes.

• Understanding of embedded communication protocols, including CAN, SPI, I2C, UART, USB, Ethernet, or similar technologies.

• Knowledgeable with integrated development environments (IDE) for projects.

• Knowledgeable with tools for static/dynamic analysis, memory management, code coverage and techniques for analyzing software.

• Knowledge in creating estimates for code implementation time/resource for assigned tasks and projects.

• Familiarity with regulatory and compliance standards applied to the SDLC (Software Development Life Cycle).

• Experience using source control systems such as GitHub, Perforce or similar, including branching, merging, code reviews, and release management workflows.

• Knowledge in build systems and automation tools such as Jenkins, CMake, or equivalent CI/CD frameworks.

$102,600 - $171,000 USD Annual