Engineer II Manager Engineering Testing Analysis

AbbVie is looking for a Principal Engineer to lead the Lake County Engineering Testing & Analysis group (ETAG) within Combination Product Development & Drug Delivery. This is a key role with a direct impact on AbbVies exciting and rapidly growing portfolio of combination products with a major focus on continuous infusion and subcutaneous injection systems.

The Principal Engineer will direct project activities and professional development of a group of testing engineers by effectively mentoring guiding and supervising personnel. He/she will serve as a technical lead on his/her own projects while contributing engineering insights into multiple other projects. Critical to this role will be the ability to independently conceive execute and communicate novel multidisciplinary approaches and development strategies that achieve project and area goals.

Responsibilities:

• Effectively function as a principal investigator for the ETAG function generating original technical ideas and strategies. Serve as Technical Lead on one or more development projects.
• Demonstrate creative out of the box thinking to solve difficult problems and champion new technologies to achieve project goals.
• Generate new technical proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
• Primary author of technical and regulatory documents and/or primary inventor of patents.
• Mentor/supervise a team of engineers and/or scientists and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
• Supervise the design and of experiments supporting feasibility development and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
• Contribute directly to technical activities including:
  • Establish and maintain lab equipment/software capabilities by authoring SOPs and qualification packages developing training troubleshooting issues and leading audit reviews.
  •  Guarantee GMP compliant framework such as SOPs for the overall Quality System training requirements and infrastructure.  
  • Define develop and validate/transfer test methods.
  • Create verification plans protocols records and reports. Support investigations and issue resolutions. Coordinate testing across multiple test executors and manage test schedules.
• Analyze document and present results to crossfunctional teams. Ensure scientific insights are leveraged across projects.
• Promotes harmonized development strategies across CPD projects and sites. 
• Stimulate innovation and foster an inclusive and collegial work environment.

Qualifications :

• A degree in an engineering field (mechanical materials packaging bioengineering): BS or equivalent education and extensive typically 12 years of experience; MS or equivalent education with typically 10 years of experience; PhD with typically 4 years of experience
• 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
• Demonstrated effective people leadership deliverables produced on time and personnel development plans in effect.
• Recognized and sought out as an expert in his/her discipline.
• Project management competencies in budgeting (External Spend and Capital Expenditure) and resource planning as well as scheduling and tracking of project tasks. Ability to manage multiple complex projects.
• Proficiency in MS Office MS Project Solidworks.
• 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 international 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: 

• This is an onsite opportunity located in AbbVies NorthChicago offices. 
• 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 shortterm incentive programs. 
• This job is eligible to participate in our longterm 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 serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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 status as a protected veteran or any other legally protected group status.

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