BD (Becton, Dickinson and Company) Sr. Manufacturing Engineer in Tempe, Arizona
Job Description Summary
• Drive development and execution of mold replacement strategy for PI products in conjunction with business platforms, procurement. BDI mold SME's, site mold engineers and business unit sustaining engineering. Will ensure adequate resources are budgeted across the organization to support.
• Work in tandem with product transfer teams to support site execution of product transfers as needed for PI products.
• Travel to sites/suppliers as needed (as permitted) to provide support and address urgent needs.
• Provide support to product change projects as needed. Provide technical support and interface with business unit and sites to ensure alignment of validation requirements and approach.
• Coordinates and drives resolution to difficult manufacturing process problems at mfg sites & 3rd party suppliers.
Essential Job Functions
Drive development and presents comprehensive business case for recommended mold replacement strategy and drives the alignment/implementation of that strategy.
Works with Mold SME’s & sites to design mold tools of varying types for PI products. Helps obtain approvals and builds when required the necessary tooling for products.
Lead for annual tooling and capital investment budget across mfg sites to ensure coverage for replacements and additional tools for lifecycle & capacity planning as part of mold strategy.
Completes mold & tool assessment database across all PI.
Training of mfg site personnel on maintaining mold maintenance/replacement system.
Reviews processes, methods, tooling, procedures, and production controls for product/design transfers as needed.
Reviews & provides guidance on validation protocols, transfer plan validations, risk assessments, Installation Qualifications, Operation Qualifications, Performance Qualifications, as needed.
Reviews & provides guidance on specifications, bill of materials, drawing, operating procedures and any other documentation needed to manufacture, test or purchase products.
Recommends incorporation of new technology for Company applications where feasible and practical.
Provides design of experiments whenever an equipment or process improvement is required and define new set up parameters and process limits to establish requirements per Corporate Guidelines.
Project planning and execution.
Knowledge of CMP’s, OSHA, and ISO 9000 requirements and Continuous Process Improvement techniques.
Strong knowledge and experience in injection molding.
Strong background in statistical Process Control.
Must have knowledge in Qumas, Microsoft Projects Planning, FMEAS, HACCP and validation preparation and documentation (master protocol, risk assessment, IQ, OQ, and PQ).
Able to work as a Team member.
Excellent analytical, organizational, interpersonal, written, and verbal communications skills.
Education and/or Experience:
BS Degree in Engineering, preferably in Chemical, Industrial or Mechanical Engineering.
Five (5) or more years of experience as a Manufacturing Engineer, preferably with tool and machine design experience in the Pharmaceutical and/or Medical Devices manufacturing environment.
Experience in capital appropriation evaluation and analysis.
Primary Work LocationUSA AZ - Tempe Headquarters
Additional LocationsDOM Santo Domingo - Las Americas
Work ShiftNA (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.