Description
Job DescriptionDesign 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.
Primary Responsibilities:
- 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.
- Design, code and implement software for real time embedded control systems.
- 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.
Minimum/Special Qualifications:
- 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, C++, Visual Basic and assembly language.
- Embedded systems design, microcontroller, microprocessor and DSP system development.
- Proficiency in real-time embedded control system design, GUI implementation and multithread programming.
- In-Circuit debuggers/emulators experience.
Highly Desirable:
- Calibration software development experience.
- 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.
- Proficiency in technical computing tools like MATLAB or Mathematica.
- Understanding of relational databases and SQL
- Interest in basic web design using PHP, Javascript (jQuery), HTML, and CSS
To find out more about Real please visit www.realstaffing.com