Project Lead

Abbott LaboratoriesAustin, TX
Onsite

About The Position

As a Project Lead you will manage and maintain the technical qualification of Tier II component suppliers and supplier processes, supervise the resolution of complex technical issues and lead the supplier development team for designated components / processes. The position provides technical support and expertise to process optimization, validation and technical leadership in tool design to custom part suppliers and team members. Drives activities at the supplier(s) to ensure that production start-up through to scale up to increased volumes are achieved within ADC requirements.

Requirements

  • B.S. Engineering or B.S. Science Degree with Engineering experience
  • 5 plus years’ experience of working in a manufacturing environment in contract or OEM with preference for injection molding and/or medical device experience.
  • Prior Experience of analyzing First Article Inspection (FAI) and PpK data.
  • Familiarity with cGMP, FDA and ISO regulated environment.

Nice To Haves

  • B.S. Degree in Polymer or Mechanical Engineering a plus
  • Qualified in Injection Molding Process development SIM study to Master Molder level would be an advantage.
  • Experience in work with tooling manufacturing sites including interacting with toolmakers and equipment suppliers for design & FAT qualification actives.
  • Equipment design and specification with Validation experience.
  • Able to demonstrate DOE & greenbelt DMAIC methodologies.
  • Knowledge of stamping, forming, packaging, adhesive manufacturing would be desired.
  • Technical project management preferred.
  • Previous experience in introducing new materials including polymer pack material is preferred.

Responsibilities

  • Technical lead to manage large scale, complex multiple projects.
  • Coordinate and lead the utilization internal/external resources to achieve project goals.
  • Provide technical leadership and expertise in process characterization, molding SIM studies, validation activities to custom part suppliers
  • Support custom part suppliers in the qualification of new and existing tools, improve process optimization and help resolve supplier technical issues.
  • Identify, Characterize and Document all key process variables included in Design Transfer.
  • Optimizes the manufacturing processes at suppliers to provide sustainable gains in cost effectiveness and quality improvement through capital projects, statistical analysis, design of experiments and procedural changes.
  • Responsible for compliance with applicable Corporate and divisional policies, GMP and performing duties as assigned by management

Benefits

  • Career development with an international company where you can grow the career you dream of.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
  • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
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