Scientist I/II, Engineering - Design Verification Engineer
AbbVie
August 23, 2026
Remote friendly (North Chicago, IL)
United States
$84,500 - $162,000 USD yearly
Operations
Responsibilities:
- Serve as Subject Matter Expert (SME) on lab capabilities (GMP/non-GMP equipment, software, data acquisition) for Design Verification testing.
- Qualify equipment/software; develop/maintain SOPs and work instructions; resolve issues; train operators; represent combination product development on cross-functionally validated systems.
- Lead lab verification: develop protocols and test methods, execute tests, analyze data, write reports; support investigations and issue resolution; present results to cross-functional teams.
- Use volumetric accuracy equipment and force testing machine; familiarity with Zwick, viscometers, climate chambers is a plus.
- Support statistical data analysis (MiniTab is a plus).
- Develop, validate, and transfer test methods.
- Use machine shop tools, SolidWorks, and 3D printers to design and verify test fixtures.
- Prefer experience with SolidWorks, Electronic Lab Notebook (ELN) software, and electronic DHF tools (e.g., Polarian).
- Work independently under guidance; comply with regulatory/safety requirements; collaborate with Quality, Regulatory Affairs, Clinical, and global partners.
Qualifications:
- Bachelor’s (typically 10+ years) or Master’s (typically 8+ years) or PhD (no industry experience required).
- 3+ years in medical device or combination products.
- Experience with design control, risk management, and regulatory standards (ISO; FDA; ASTM).
- Knowledge of GMP, Design Controls, GDP, and FDA regulations; strong theoretical and practical understanding in scientific discipline.
Benefits (if applicable): paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k); eligible for short-term incentive programs.
- Serve as Subject Matter Expert (SME) on lab capabilities (GMP/non-GMP equipment, software, data acquisition) for Design Verification testing.
- Qualify equipment/software; develop/maintain SOPs and work instructions; resolve issues; train operators; represent combination product development on cross-functionally validated systems.
- Lead lab verification: develop protocols and test methods, execute tests, analyze data, write reports; support investigations and issue resolution; present results to cross-functional teams.
- Use volumetric accuracy equipment and force testing machine; familiarity with Zwick, viscometers, climate chambers is a plus.
- Support statistical data analysis (MiniTab is a plus).
- Develop, validate, and transfer test methods.
- Use machine shop tools, SolidWorks, and 3D printers to design and verify test fixtures.
- Prefer experience with SolidWorks, Electronic Lab Notebook (ELN) software, and electronic DHF tools (e.g., Polarian).
- Work independently under guidance; comply with regulatory/safety requirements; collaborate with Quality, Regulatory Affairs, Clinical, and global partners.
Qualifications:
- Bachelor’s (typically 10+ years) or Master’s (typically 8+ years) or PhD (no industry experience required).
- 3+ years in medical device or combination products.
- Experience with design control, risk management, and regulatory standards (ISO; FDA; ASTM).
- Knowledge of GMP, Design Controls, GDP, and FDA regulations; strong theoretical and practical understanding in scientific discipline.
Benefits (if applicable): paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k); eligible for short-term incentive programs.