Embedded Software Engineer

Position Overview

The Software Engineer will lead embedded software development efforts for complex medical device projects. This individual will be responsible for translating customer requirements into scalable software solutions, defining software architecture, ensuring compliance with regulatory standards, and guiding software teams through the entire product development lifecycle.

This role combines hands-on technical execution with leadership responsibilities, requiring strong expertise in embedded systems, software architecture, regulatory compliance, and team leadership.

Key Responsibilities

• Lead embedded software development for medical device and regulated-industry projects.
• Define system architecture and software design while balancing performance, safety, security, maintainability, and cost considerations.
• Collaborate with clients and cross-functional engineering teams to develop and allocate system requirements.
• Provide project estimates and support milestone planning.
• Guide software teams through architecture, design, implementation, testing, and integration activities within an Agile development environment.
• Manage task planning, delegation, and execution to ensure successful project delivery.
• Contribute directly to software development, testing, and integration activities.
• Ensure software quality through code reviews, technical mentorship, and adherence to best practices.
• Drive process improvements, software standards, and internal development initiatives.
• Maintain compliance with FDA regulations, IEC 62304, and cybersecurity requirements.

Required Qualifications

• Bachelor's or Master's degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
• 5+ years of embedded software development experience, preferably within the medical device industry or another regulated environment.
• Prior experience leading software teams or serving in a technical lead capacity.
• Strong communication skills with the ability to engage both technical teams and customers.
• Experience with embedded Linux development, including Yocto Project, BSP development, and device driver configuration.
• Proficiency in C++, C#, and/or C programming, including multithreaded and multi-process application development.
• Strong troubleshooting and problem-solving skills in complex software environments.
• Experience developing graphical user interfaces using modern software design patterns such as MVC, MVVM, or MVP, preferably with Qt/QML.
• Experience with microcontroller programming, RTOS environments (such as ThreadX), and hardware debugging tools.
• Deep understanding of software architecture, design, verification, and testing methodologies.

Work Environment

• Cross-functional teams consisting of Software, Electrical, Mechanical, Systems, Test, Quality, and Program Management professionals.
• Exposure to projects supporting both established medical technology companies and innovative startups.
• Strong engineering culture focused on quality, collaboration, continuous improvement, and technical excellence.

Eligibility

• Must be authorized to work in the United States.