Principal Engineer, Engineering Testing & Analysis (Team Lead)

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

AbbVie is looking for a Principal Engineer to lead the Irvine Engineering Testing & Analysis group (ETAG) within Combination Product Development (CPD). This is a key role with a direct impact on AbbVie’s exciting and rapidly growing portfolio of combination products, with a major focus on Eye Care and Neurotoxins products.

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 multi-disciplinary approaches and development strategies that achieve project and area goals.

Responsibilities:

• Effectively function as a principal investigator for the Lab Testing 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 one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.
• Supervise the design and execution 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 cross-functional 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.

• A degree in an engineering field (mechanical, materials, packaging, bioengineering): 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
• 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

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 AbbVie’s 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html