Senior Design Verification Engineer I

Responsibilities

• Serve as Subject Matter Expert (SME) on lab capabilities, including GMP and non-GMP equipment, software, and data acquisition systems for Design Verification testing.
• Responsible for equipment and software qualification, SOPs and work instructions, resolving issues, training operators, and representing combination product development on cross-functionally validated systems.
• Lead lab verification activities, including design verification protocol development, test method development, test execution, data analysis and documentation, and report writing.
• Support investigations and issue resolutions. Present results to cross-functional teams.
• Utilize volumetric accuracy equipment and force testing machine. Familiarity with Zwick, viscometers, climate chambers, etc. is a plus.
• Support data analysis using statistics, experience with MiniTab is a plus.
• Develop, validate, and transfer test methods.
• Utilize machine shop equipment, SolidWorks, and 3D printers to design and verify test method fixtures.
• Experience with SolidWorks, Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred.
• Work in an independent manner under the guidance of a supervisor or technical lead.
• Comply with applicable policies and procedures, regulatory and safety requirements.
• Work on cross-functional teams including Quality, Regulatory Affairs, Clinical Team, and global partners.

Qualifications

• Bachelor’s Degree or equivalent education and typically 10+ years of experience, Master’s Degree or equivalent education and typically 8+ years of experience, PhD and no industry experience necessary.
• 3+ years of experience in medical device or combination products.
• Knowledge of Good Manufacturing Practices (GMP), Design Controls, Good Documentation Practices (GDP), and FDA regulations.
• Possess thorough theoretical and practical understanding of own scientific discipline.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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