Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
The Principal Engineer will manage and maintain the technical qualification of injection molding 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 molding process optimization, molding 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.
1. Technical lead to manage large scale, complex multiple projects.
2. Coordinate and lead the utilization internal/external resources to achieve project goals.
3. Provide technical leadership and expertise in molding process characterization, SIM studies, validation activities to custom part suppliers
4. Support custom part suppliers in the qualification of new and existing molds, improve process optimization and help resolve supplier technical issues.
5. Identify, Characterize and Document all key process variables included in Design Transfer.
6. 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.
7. Responsible for compliance with applicable Corporate and divisional policies, GMP and performing duties as assigned by management
Engineering Degree B.S. Engineering or B.S. Science Degree with Engineering experience or B.S. Degree in Polymer or Mechanical Engineering a plus. 5 plus years' experience of working in an injection molding environment in contract or OEM. Prior Experience of analyzing First Article Inspection (FAI) and PpK data Familiarity with cGMP, FDA and ISO regulated environment. 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 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. Experience with RJG pressure transducers for process control would be desired. Technical project management preferred. Previous experience in introducing new materials including polymer pack material is preferred.