- Develop protocols and sequences to test multiple aspects of software and firmware design, including code for signal detection, electro-mechanical controls, signal measurements, post-processing analysis and algorithms, data transfer, and human interface aspects in medical device software.
- Establish re-usable test standards and processes to ensure optimum and thorough software V&V tasks within FDA and MDD regulatory frameworks.
- Use thorough practical experience in translating software requirements specifications to software test protocols.
- Provide technical direction and technical expertise to other V&V and test engineers and interns.
- Provide test support to a variety of cross-functional areas including Production and
- Manufacturing Engineering.
- Document and execute incremental test solutions for software defects and enhancements.
- Design, develop, and support software tools used for testing.
- Support change control through software-test representation.
- Other software-test-related duties as assigned.
- Bachelor of Science degree in Software, Computer or Electronics Engineering, or Computer Science.
Experience Years & Type10+ years of software test experience; preferably 5+years of experience performing software quality assurance for medical devices in a GMP manufacturing environment
- Experience with Linux operating environments preferred
- Experience with connectivity solutions testing, especially in medical device applications (secure WiFi, Ethernet, HL7, etc.)
- Experience with testing database implementations
- Experience in developing software tools in C/C++, C#
- Experience in configuring and maintaining an automated build server (e.g., Jenkins) installation
- Constant hearing, talking and near vision. Frequent sitting (80%) and standing (moving about) (20%). Occasional handling, fingering and reaching.
- Occasionally lifts and carries up to 50 pounds.