Test Engineer 3-USD/SW V&V Test Engineer

Role: Test Engineer 3 / Sr. Software Verification and Validation (V&V) Test Engineer
Duration: 6 months (possible conversion or extension)
Location: San Diego, CA - Flex for Remote with some travel

Travel Required: YES
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.

Education Requirements:
Engineering or Computer Science

Required Skills (top 3 non-negotiables):
SW V&V – 5 years minimum
Strong understanding of FDA regulations (21 CFR Part 820)
Experience with statistical tools (JMP preferred / Minitab)
Exposure to manufacturing systems and physical hardware
 
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

Software Skills Required:
MS Suite (Word, Excel, PowerPoint, Teams)
Nice to have: Labview, TestStand

Preferred Skills (nice to have):
Background in analytical chemistry
History of working with NI-based test equipment
Knowledge of SDLC / GAMP 5

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/daily.