Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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 LocationsESP San Agustin del Guadalix
Work ShiftNA (United States of America)
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- Team player
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.