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 (Medical Devices)
Builds
Firmware, communication software, and automated manufacturing test systems for medical devices
Domain
Healthcare / Medical Devices / Embedded Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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
ASQ CSQE certification, prior medical device experience, enterprise/cross-division business unit model experience
Technologies
Visual Studio, Code Collaborator, Coverity, Parasoft DTP, Git, Jira, Subversion, ClearQuest, DOORS, Bugzilla
Responsibilities
Plan and execute manual and automated test plans, procedures, scripts, and reports; Lead test planning and execution activities; Develop and maintain SOPs, specifications, and test procedures; 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 and results from 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
