Software Engineer

About the role

You will be a core team member in the design and development of medical products and systems. This role contributes to all phases of product design, including initial requirements definition, conceptualization, feasibility assessment/demonstration, detailed design including engineering analysis and testing; verification testing and documentation, and transfer to the client (or manufacturing) and follow-on support as needed. You will work on projects that typically involve teams from multiple disciplines: mechanical, electrical, software, systems, industrial design, and human factors.

Responsibilities

• Participate in shaping product design through requirements definition, architectural discussions, and early feasibility development for embedded software solutions
• Design, develop, and maintain firmware for microcontroller based embedded systems used in medical and commercial devices
• Implement embedded software using C/C++ and other appropriate technologies for resource constrained systems
• Collaborate with electrical and systems engineers to integrate firmware with hardware components and subsystems
• Develop and maintain automated build, test, and deployment processes using CI/CD pipelines appropriate for embedded development
• Generate and maintain software design documentation, architecture descriptions, and traceability artifacts in accordance with quality and regulatory processes
• Contribute to verification and validation activities including unit testing, integration testing, and system level testing
• Apply risk based development approaches and support hazard analysis and software risk control activities
• Troubleshoot, debug, and resolve software and system integration issues during development and verification phases
• Work with project management to complete assigned technical tasks within project scope, schedule, and budget
• Communicate technical results and development progress to project leadership and clients through written and oral presentations

Qualifications

• Bachelor’s degree in Computer Engineering, Electrical Engineering, Computer Science, or a related technical field
• Strong programming skills in C and/or C++ for embedded systems
• Experience developing software for microcontroller based platforms
• Familiarity with embedded debugging tools such as JTAG debuggers, oscilloscopes, and logic analyzers
• Experience working in multidisciplinary engineering teams developing complex systems
• Strong problem solving skills and ability to work independently on technical tasks
• Effective written and verbal communication skills for technical documentation and collaboration

Preferred Qualifications

• Experience developing software for medical devices or diagnostic instrumentation
• Familiarity with IEC 62304 software lifecycle processes for medical device development
• Understanding of FDA regulatory expectations for software in medical devices and development within ISO 13485 quality systems
• Experience developing firmware for ARM Cortex M (32 bit) microcontroller architectures, with familiarity with vendors such as STMicroelectronics (e.g., STM32)
• Experience with real time operating systems (RTOS) or real time embedded design
• Experience with hardware software integration and board level bring up
• Experience designing or maintaining CI/CD pipelines for embedded software development and automated testing
• Experience supporting design verification and validation activities for regulated products