Principal Engineer - Packaging and Sterilization

Principal Engineer - Packaging and Sterilization

Objective

This position is a Shared Services Resource that provides guidance and direction of medical and commercial packaging and sterilization programs through development. Act as a global resource to medical and commercial production facilities to support plant efforts. Support initiatives to increase Phillips-Medisize market share by increasing value-added capabilities.

Key Responsibilities:

  • Identify best practices and drive continuous improvement activities across Phillips-Medisize
  • Create and lead a Global Packaging Council within Phillips-Medisize and represent Phillips-Medisize on the Global Engineering Packaging Council within the Molex organization.
  • Partner with management on setting goals for business implementation and operational effectiveness
  • Interpret and negotiate packaging and sterilization requirements to meet customer needs
  • Act as a packaging resource to partner with Sales, Cost Estimators, Purchasing and Business Development on quoting and sourcing programs with packaging materials and/or services and trade show support
  • Set top-level project implementation deliverables and dates and manage the execution
  • Identify software, hardware and equipment needs for packaging and labeling operation
  • Develop manufacturing line layout plans and determine the space needed for device assembly and packaging
  • Identify and monitor the supporting resources required for various stages of business implementation, on-going support of the packaging operations and drive task-level management
  • Monitor and justify packaging resource requirements
  • Develop and manage project schedule(s) required to implement packaging components and equipment
  • Partner with Project Engineers, Manufacturing Engineers, Packaging Engineers, and Program Managers to successfully transition programs from development to production 
  • Coordinate the transfer of contracted packaging/assembly jobs to Phillips-Medisize facilities
  • Remain up-to-date on the latest trends and technologies in the packaging industry along with Regulatory Requirements
  • Instill a mindset that will proactively cause those involved in the business to put all GMP regulations at the forefront of their day-to-day activities
  • Build partnerships with suppliers and packaging contractors
  • Support AQP Process Road Map and checklist for medical assembly/packaging and sterilization programs
  • Partner with Regulatory/Validation personnel related to Terminally Sterilized Packaging Systems and Sterilization Management
  • Extended travel to Phillips-Medisize facilities, vendors, and customers may be required to support business needs.  Travel estimated at 20%
  • Support MBM (Market Based Management) Principles
  • Some programs may have vision requirements
  • Other duties as assigned
  • Safety/Environmental:
    o Where applicable, individual is pre-planning safety into work activities to improve performance
    o Proactively identifies safety concerns
    o Complies with Environmental Management System program SOP’s/WI, Policy & Program elements and encourages responsible use of resources
  • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction

Education/Experience

  • Bachelor’s degree in packaging or equivalent industry experience  
  • Minimum of five (5) years related medical packaging experience
  • Minimum of three (3) years of project management experience
  • Experience in sterilization preferred.
  • Must be familiar with current regulatory trends and packaging / sterilization requirements 

Required Skills/Competencies

  • Sound management and leadership skills
  • Excellent written, verbal and presentation communication skills
  • Proven ability to work at/with multiple levels in an organization
  • Ability to coordinate multiple projects at one time
  • Experience in capital equipment purchasing, manufacturing operations and regulatory along with knowledge of ISO 9000, ISO 13485, ISO 11607, ISO 11137, ISO 11135 and GMP guidelines
  • Ability to work with internal and external customers in a productive and team approach 

Questions and application

Please send questions and your application to Steve Weghorn, Global Technical Services Manager: steve.weghorn@phillipsmedisize.com