Principal Research Scientist I Eng Design Verification Engineer

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 AbbVies eye care and aesthetics 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 AbbVies 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. Experience using Zwick and flow measurement equipment is preferred. Familiarity with 3D printing CT Scanners Viscometers Climate Chambers etc. is a plus.
• 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 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.  Ability to prepare technical reports and presentations. Demonstrated scientific communication and presentation skills including the ability to present to senior management.
• Willingness and ability to travel both domestic and internationally up to 10% of the time

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 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. 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. 

• This job is eligible to participate in our long-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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time