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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 1 day ago
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