Senior Design Verification Engineer – Med Devices

AbbVie Inc.

North Chicago (IL)

On-site

USD 97,000 - 184,000

Full time

3 days ago

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Benefits offered by this job

Medical/dental/vision insurance

401(k)

Job summary

AbbVie Inc. in the United States is seeking a Senior Scientist I, Engineering – Design Verification Engineer to join our Combination Product Development & Drug Delivery Team to advance new drug/device products.

You will lead verification activities, qualify equipment and software, develop test methods, and collaborate across Quality, Regulatory, Clinical teams. This role requires 10+ years in medical devices, GMP knowledge, and strong communication and problem-solving skills; SolidWorks,

Qualifications

Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent education.
10+ years of experience in medical device or combination products.
Knowledge of GMP, Design Controls and FDA regulations.

Responsibilities

Lead lab verification activities, including design verification protocol development, test method development, test execution, data analysis and documentation, and report writing.
Serve as SME on lab capabilities, including GMP and non-GMP equipment, software, and data acquisition systems for Design Verification testing.
Ensure equipment and software qualification, SOPs and work instructions, resolving issues, training operators, and representing combination product development on cross-functional validated systems.
Develop, validate, and transfer test methods.
Utilize machine shop equipment, SolidWorks, and 3D printers to design and verify test method fixtures.
Work in an independent manner under the guidance of a supervisor or technical lead.