Senior Scientist I, Engineering - Design Verification Engineer
AbbVie
Senior Scientist I, Engineering position focused on design verification for combination drug-device products. Leads lab testing activities, equipment qualification, and method development within a cross-functional biopharmaceutical team.
Responsibilities
- Serve as subject matter expert on GMP and non-GMP lab equipment, software, and data systems for design verification
- Lead design verification protocol development, test method development, execution, analysis, and report documentation
- Develop, validate, and transfer test methods; design verification test fixtures using SolidWorks and 3D printers
- Manage equipment and software qualification, SOPs, troubleshooting, and operator training
- Support cross-functional teams including Quality, Regulatory Affairs, and Clinical on combination product development
Requirements
- Bachelor's in Mechanical/Biomedical Engineering with 10+ years experience, or Master's with 8+ years, or PhD
- 3+ years experience in medical devices or combination products
- Knowledge of GMP, Design Controls, GDP, and FDA regulations
- Familiarity with ISO compliance, FDA and ASTM standards
- Experience with design control and risk management methodologies
- SolidWorks, Electronic Lab Notebook software, and Polarian DHF tools preferred
Vacancy posted 2 days ago
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