Principal Research Scientist I Eng - Design Verification Engineer

AbbVie • North Chicago, IL

107d

About The Position

The AbbVie Device & Combination Product Development (DCPD) team provides expertise to enable the development of drug delivery systems for use with AbbVie therapeutic products as well as bespoke medical device development to support AbbVie's eye care and aesthetics portfolios. In this role, 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. 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. You will independently conceive, execute, and communicate novel multi-disciplinary development strategies that achieve project and area goals. We are looking for an individual with a comprehensive knowledge of development of medical devices and drug delivery systems to support AbbVie's therapeutic pipeline.

Requirements

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience required.
• A degree in an engineering field, preferred: mechanical, materials, packaging, bioengineering.
• Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
• Significant background in engineering testing and analysis including direct experience of test equipment validation (IQ, OQ, PQ) is required.
• Expertise in statistical analysis.
• Significant documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports.
• Expertise with Electronic Lab Notebooks (ELN) and Design History File tools such as Polarion/LinkUs.
• Proficiency in MS Office, SolidWorks, MATLAB, LabView, Minitab.
• Lean Six Sigma, 5S experience desired.
• Good communication skills, both written and oral.
• Willingness and ability to travel both domestic and internationally, up to 10% of the time.

Responsibilities

• 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.
• Lead verification activities within cross-functional teams.
• 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.
• Define, develop, and validate test methods.
• Implement new testing approaches for state-of-the-art testing & verification.
• Drive global harmonization of development & verification processes.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Short-term incentive programs
• Long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree