Senior Design Verification Engineer I
Core
Lead lab verification activities and serve as Subject Matter Expert for GMP/non-GMP equipment, software, and data acquisition systems for drug/device combination product development.
Role type
Senior Design Verification Engineer (Biopharmaceuticals/Medical Devices)
Builds
Design verification protocols, test methods, and validation reports for combination products
Domain
Biopharmaceuticals / Medical Devices / Drug Delivery Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design verification, GMP compliance, Design controls, Risk management, Regulatory standards (ISO/FDA/ASTM), Statistical analysis, Test method development, Equipment qualification, SOP creation, Cross-functional collaboration
Preferred skills
Zwick machine operation, Viscometer usage, Climate chamber operation, MiniTab, SolidWorks, 3D printing, Electronic Lab Notebook (ELN), Polarian
Technologies
Zwick, Viscometers, Climate chambers, MiniTab, SolidWorks, Electronic Lab Notebook (ELN), Polarian
Responsibilities
Develop and validate test methods, Execute design verification protocols, Qualify equipment and software, Train operators, Analyze test data, Write verification reports, Resolve technical issues
Seniority
Senior, hands-on IC