AbbVie Lead Design Verification Engineer, Combination Product Development , R&D in North Chicago, Illinois
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .
As part of the AbbVie R&D function, contribute to the development of exciting new drug-device combination products. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on people’s lives.
You will be leading programs in development of robust drug delivery systems at the intersection of engineering and biopharmaceutics, as well as improving capabilities within our state-of-the-art laboratories. In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of drug delivery systems from autoinjectors to advanced electromechanical infusion pump systems. Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use whether it is a clinical program or a commercial launch. You will independently conceive, execute, and communicate novel multi-disciplinary development strategies that achieve project and area goals.
Define verification strategy and lead planning and execution of the activities to meet program objectives. Create verification plans, protocols, records, and reports. Determine sample size strategy based on strong scientific rationale conforming to internal and regulatory guidelines.
Define, develop, and validate test methods.
Lead execution of test procedures and writing of protocols supporting engineering testing and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams.
Lead root cause investigations and issue resolutions.
Work in an independent manner alongside the technical lead.
Complies with applicable policies and procedures, regulatory and safety requirements.
Expected to recommend improvements in design, processes, execution of a project or task as well as the maintenance of a program.
Bachelor’s degree in Engineering, Science, or related discipline. Mechanical Engineering or Biomedical Engineering preferred.
Typically 10-14 (BS) or 8-12 (MS) years of experience in medical device or combination products. Additional education (PhD) may substitute for some years of experience.
Significant documentation experience including technical reports, design verification plans, protocols, etc. is a must.
Demonstrated problem solving skills and fundamental technical depth is essential.
Knowledge of GLP, GMP, and FDA regulations.
Job level will be commensurate with experience - available job levels include Senior Engineer I, Senior Engineer II, and Principal Engineer I
Hands-on experience with medical device systems with embedded software, mechanical, and electromechanical systems strongly preferred. Knowledge in basic statistics and Six Sigma statistical techniques is a plus.
Experience using Zwick and flow measurement equipment is preferred. Familiarity with 3D printing, CT Scanners, Viscometers, Climate Chambers, etc. is a plus.
Familiarity with Microsoft Project and Document Management System tools such as Link-US, DOORS, or Cockpit is desired. Experience with engineering tools such as SolidWorks, Minitab, Engineering Lab Notebook (ELN) is a plus.
Strong desire to flex and acquire skills in connecting functional areas of engineering and med-tech as well as process understanding of pharmaceutics as part of a longer-term growth and development within organization.
Self-driver with proven track record of actively engaging and working in a matrixed environment with cross-functional teams and getting things done.
Other attributes include strong decision making, and communication (spoken and written) skills, attention to details and commitment to accuracy.
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Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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