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Senior Engineering Lead

1 month ago

Irvine, California, United States AbbVie Full time

About the Role:

Absorb the opportunity to lead the Irvine Engineering Testing & Analysis group (ETAG) within Combination Product Development (CPD) at AbbVie. As a Principal Engineer, you will direct project activities and professional development of a group of testing engineers by effectively mentoring, guiding and supervising personnel.

Key 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.

Requirements:

  • 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.
  • 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

About 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.

For more information about AbbVie, please visit our website.