Software Development Quality Engineer II
Core
Execute and maintain quality engineering methodologies for firmware, communication software, and automated manufacturing test systems to ensure software reliability and patient safety.
Role type
Software Development Quality Engineer
Builds
Firmware, communication software, and automated manufacturing test systems
Domain
Medical devices / Healthcare / Embedded systems
Required skills
C, C++, C#, Python, Java, Git, Jira, Subversion, ClearQuest, DOORS, Bugzilla, Code Collaborator, Coverity, Parasoft DTP, V-Model, Agile/Scrum, TDD, static analysis, Design Verification and Validation (V&V), FDA regulations, GMP, ISO 13485, IEEE 1012
Preferred skills
Medical device experience, ASQ CSQE certification, enterprise/cross-division business unit model experience
Technologies
C, C++, C#, Python, Java, Visual Studio, Git, Jira, Subversion, ClearQuest, DOORS, Bugzilla, Code Collaborator, Coverity, Parasoft DTP
Responsibilities
Plan and execute manual and automated test plans, procedures, and scripts; Lead test planning and execution activities; Develop and maintain standard operating procedures (SOPs) and test protocols; Execute Design Verification and Validation (V&V) activities including hands-on testing and root-cause analysis; Participate in requirements reviews, design reviews, and code inspections; Review and assess test protocols generated by other functional groups; Support product Risk Management activities; Ensure Design History File (DHF) compliance; Support internal and external audits and inspections.
Seniority
Mid-level, hands-on IC