Senior Software Engineer

Job Title: Senior Software Engineer

Reports To: Electronic Systems Manager, Research and Development

Position Summary:

Design and develop embedded system software for medical devices. Demonstrate a comprehensive knowledge and track-record of application of software engineering principles and modern practices. Responsibilities include research, design and development, test and detailed documentation of complex software systems for medical products. The position will require original thinking and application of sound engineering principles to develop new products and technologies in an exciting multidisciplinary environment.

Essential Functions:

  • Design, code and implement software for real time embedded control systems.
  • Help develop as well as follow policies and procedures to complete and accurately document engineering activities and comply with FDA/EN 62304 design controls for medical device development.
  • Design and execute software testing as necessary to verify the design and performance of the device software.
  • Participate in software validation activities including code reviews and validation test documentation development.
  • Assist with clinical studies for design validation, verification and product enhancement.
  • Provide software engineering leadership in an inter-disciplinary medical product development team.
  • Generate software requirements specification, risk assessment and software design history documentation.
  • Work closely with hardware engineers to architect product design to meet specifications and select optimal hardware devices for the product.

Highly Desirable:

  • Excellent understanding of Software Architectural issues when designing embedded systems.
  • Knowledge of electronics to facilitate interfacing to product hardware.
  • Watchdog and safety processor implementation experience.
  • Excellent understanding of methods used to identify and trace system requirements through design process.
  • Proficiency in development of software plans and specifications based on high-level requirements.
  • Proficiency in development of design verification and validation process procedures, protocol development and testing.
  • Familiarity with an Integrated Development Environment tools used for embedded development.

Education and/or Experience:

  • BSEE/BSCS or equivalent with 7+ years’ experience or MSEE/MSCS or equivalent with 5+ years’ industry experience with real-time embedded system software design and development required.
  • 3+ years’ experience in Medical device development experience following FDA/EN 62304 Quality System Requirements including an understanding of IEC 60601 and IEEE software development standards.
  • Highly skilled development experience in C and assembly language.
  • Embedded systems design for microcontrollers/microprocessors.
  • Proficiency in real-time embedded control system design, low level drivers, GUI implementation and RTOS programming.
  • In-Circuit debuggers/emulators experience.

If you would like to apply for this position, please email your resume to