Sr. Test Engineer

To support the SW V&V process for our medical device manufacturing processes:
Generate user requirements (URS) for systems containing software, hardware, firmware
Generate test plans and protocols (PLN) for verifying all user and software requirements
Execute all system-level testing
Write SW V&V report (RPT) and include evidence of test completion, explaining anomalies or deviations
Follow release process through the product lifecycle management system (Oracle)
Support release of ancillary documentation, such as engineering studies or lab-book reports (LBRs)
Participate in cross-functional team meetings and/or technical reviews
High attention to detail and excellent written communication skills required to report bugs, capture user needs and synthesize into testable requirements, and track/report progress
Knowledge of basic statistics for Measurement Systems Analysis (gage studies, statistical sampling, SPC, DOE, etc.) leveraging JMP
Note: Some time will need to be spent on-site in San Diego when performing V&V testing, or when learning the system in preparation for V&V testing. (i.e. 2 weeks at a time). 90% admin, 10% on-site physical.
Requirements:
Education: Engineering or Computer Science
10+ years of work related experience
SW V&V – 5 years minimum required 
Medical Device (21CFR part 820) required
Measurement Systems Analysis / JMP required 
Software Skills: MS Suite (Word, Excel, PowerPoint, Teams); Nice to have: Labview, TestStand

Preferences:
Knowledge of SDLC / GAMP 5 preferred
Background in analytical chemistry preferred
History of working with NI-based test equipment preferred
Case Management Experience – 3+ years preferred