Principal Research Scientist I Eng - Design Verification Engineer

Job Opportunity At AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio.

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.

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.

Qualifications

• BS or equivalent education with 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. Ability to prepare technical reports and presentations.
• Willingness and ability to travel both domestic and internationally, up to 10% of the time.

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. The 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.

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. US & Puerto Rico only.