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Staff Manufacturing Engineer - Project Manager

Apply Now Job ID R-334862 Date posted 04/10/2019

Job Description Summary

Job Description

Summary

Reporting directly to the Global Programs Director, the Project Manager is responsible and accountable for supporting the development and execution of architecture-related elements of the manufacturing strategy; this includes, but is not limited to: part and product transfers, configuration of manufacturing lines and cells, make versus buy analysis, manufacturability documentation and guidelines, and product introduction and scale-up processes. Incumbent will work on projects of a strategic nature that are high in complexity and scope. Role will primarily support BD Biosciences manufacturing operations.

Project Manger will assist in the development, alignment and implementation of strategic functional plans in support of the unit/segment business plan through three primary roles:

  • Utilize analytical skills to collect, analyze, and interpret large manufacturing network-related data sets to develop solutions to difficult business challenges. Find opportunities for product and process optimization by using data-driven models to test the effectiveness of different courses of action.
  • Develop and implement processes and best practices to ensure robust manufacturing-related documentation and, where appropriate, provide leadership on documentation remediation activities.
  • Lead complex part / product manufacturing and technology transfers to realize and implement the long-term vision of the EMI manufacturing network.

Project Manager is expected to work on problems of moderate to large scope where decisions and recommendations are made in the face of uncertain and dynamic conditions, where errors in judgment may seriously impact customer or supplier relationships, result in substantial loss of scheduled production, deterioration of product/service quality, or seriously affect the financial position of the business units.

Responsibilities

  • Performs complex analyses to determine optimal manufacturing network design aligned to both business and functional objectives. Responsible for recommending methodologies and decision frameworks related to network architecture, including make versus buy.
  • Key member and often leads large cross-functional project teams in support of key operational objectives, including major site architecture decisions (i.e. proposed new facilities). Establishes milestones and monitors adherence to program master plans and schedules. Determines resources and skills necessary to implement assigned programs. Circulates resources, schedule and cost requirements, and design specifications to senior management and participating departments and obtains management approvals. Responsible for establishing and implementing governance for global strategic programs. Guides the successful completion of projects and programs by effectively organizing, coaching and motivating highly skilled cross-functional teams.
  • Initiate new projects by leading cross-funtional project planning workshops and project manage; scope, time, cost, quality, human resource, communications, risk, and procurement
  • Support the product design and technology transfer into manufacturing. Establish processes and procedures, create assembly and systems test documentation. Review engineering designs and documentation for completeness, clarity and manufacturability. Evaluate and qualify new suppliers. Train production personnel, oversee the efforts of more junior associates.
  • Designs and performs management of a complex nature, working with functional and multi-functional teams within defined parameters. Modifies methodologies and procedures as applicable to the project for quicker, more valid results. Ensures quality conduct of projects and programs, including design, data summary and interpretation, and review adherence to applicable regulations.
  • Demonstrates understanding of key local and global regulations affecting the business and assures compliance with those regulations. Assures that business processes and systems fulfill those regulatory requirements. Participates in an evaluation of regulatory strategy and regulatory risk. May recommend changes to practices and procedures to support compliance requirement. Deploys and communicates the need for regulatory compliance to members in functional areas.
  • Travel may be required up to 20% of the time.

Minimum Qualifications

  • Requires a BS degree: ME, EE, IE, or equivalent
  • Minimum 5 – 7 years experience in a manufacturing environment, preferably a capital equipment manufacturing environment
  • Experience with electro-mechanical systems and sub-assemblies
  • Excellent written and verbal communication skills, must have good interpersonal skills to effectively work across functions, regions and business units: conflict resolution, negotiation, and time management skills
  • Strong analytical skills with high attention to detail and accuracy
  • Problem-solving aptitude with an ability to think creatively to find innovative solutions to complex analytical questions
  • Must have proven project management experience including leading continuous improvement efforts with cross functional teams
  • Must be able to understand engineering drawings, Bills of Materials, and operational procedures
  • Experience developing manufacturing processes, writing procedures, and training affected personnel
  • Ability to be effective with minimal direction. Recognizes problems and addresses them without waiting to be instructed to do so.
  • Familiarity with ISO 9000 standards
  • Must excel in the use of personal computers: MS Word, Excel, Power Point, MS Project, Visio, Windows or Mac OS

Preferred Qualifications:

  • PMP Certifications or equivalent
  • Experience working with CM's and leading design transfer activities
  • Experience with SAP
  • Proficiency with some of the following applications: Pro-E, Solidworks, AutoCAD, MS Project, MS Access, SAP ERP, PhotoShop
  • Experience resolving technical issues in electro-machenical instruments, involving lasers, optical components, fluidic systems or digital/analog circuitry
  • Experience supporting some of the following commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA’s, plastics, power systems, product packaging, turnkey subcontractors, hardware, and labeling
  • cGMP medical device manufacturing experience with familiarity of 21 CFR Part 820
  • Experience implementing Demand Flow Technology (DFT) processes
  • Lean and Six Sigma experience and/or certifications

#LI-OPS 

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

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All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com