About the Role: The Principal Embedded Software Design Engineer will work independently and collaboratively with team members to ensuring that software and systems are thoroughly tested to meet design quality and performance standards and evaluate engineering solutions in support of new product and technology development as well as process and infrastructure development.

Responsibilities:

• Resolve complex design and implement software of embedded devices and systems from requirements to production and commercial deployment
• Implement solutions to fulfil various industrial standards requirements such IEEE and cybersecurity for software of medical devices
• Author and maintain detailed software requirements, architecture, and design documents for new products and technologies
• Develop unit, integration, and software system test methods and protocols
• Create software release notes and formally release incremental software versions
• Manage agile software development for new features, software bugs, and software-related system issues
• Assess and manage third party and open-source software
• Ensure compliance with industry standards (62304, 60601, FDA, MDR, 14971, 13485, etc.)
• Interface with internal QA and RA functions to gain and maintain alignment on software quality and regulatory requirements and strategy
• Prepare, present, and defend technical reviews of software work. Contribute to technical reviews of colleagues’ and team deliverables
• Collaborate cross-functionally with marketing, quality, regulatory, and operations throughout planning, development, verification, and production

Qualifications: Bachelor’s degree in a relevant technical field, Master’s degree is a plus

Required Skills:

• Minimum of 10+ years’ experience in analysis, design, coding, and testing C++ code for embedded systems
• Strong experience in developing software for Class III medical devices, preferably medical capital equipment. Deeply familiar with quality and regulatory requirements, standards, procedures, and documentation
• Utilize software development tools include, software development skills using C, C++, C#, QML, QT 5.5, SQL Lite, VC++, Python
• Solid programming experience in C/C++, working knowledge of QML/Qt, Python
• Experience in embedded systems design with preemptive, multitasking real-time operating systems, mutexes, watchdog timers, etc.
• Experience with ARM microprocessors and microcontrollers
• Knowledge of Linux build systems and system components, Yocto, FreeRTOS
• Strong understanding of hardware interfaces and I/O (SPI, UART, ADC/DAC, I2C, etc.)
• Experience with Git and branch integration
• Experience managing agile software development using Jira
• Experience working with electromechanical instrumentation and systems, including hands-on bring up and debugging
• Knowledge of reading schematics and component data sheets
• Strong communication, documentation, and writing skills
• Works independently with strong initiative, collaborates within software and across technical areas, leads and drives projects to completion