Program Manager

Job Post Index 225682-Sy##
Location Menlo Park, CA
Description: Description
  • Develop strong relationships with key managers in all sites within Region, and with external consultants.
  • Run EU-MDR projects and ensure they are all up to standards/regulations
  • Monitor the budgets and holding meetings
  • Cross functional coordinations and plan executing.
  • Influence/motivate senior management at sites to aspire to highest standards of Class A performance.
  • Support/motivate the local Program Managers to manage the total scope of the required changes necessary to bring their sites up to Class A standards.
  • Support/motivate the local Program Managers to manage the budget and timetable for the implementation of Class A achievement in conjunction with Chicago MM operations and the Class A consultant.
  • Establish Regional benchmarking teams from all locations to share best practice and ensure consistency.
  • Provide regular communications of project status to AI Division staff.
  • Provide training and implementation planning support to all AI Manufacturing, Affiliate and Logistics Class A program participants.
  • Plan use of external consultants to optimize costs and benefits.
Skills: Qualifications
  • Bachelors Degree in Administration, Sciences, Engineering, or Humanities.
  • 7+ years of experience
  • Experience in full scope gap analysis
  • Has risk perspective
  • Class 3 Device experience
  • Needs medical device background
  • Understands all elements of the Supply Chain initiative.
  • Able to work in a cross functional environment at management level
  • Fully understand the requirements of Class A certification, maintenance, and the perpetuation thereof.
  • Fully understand Manufacturing, Marketing and Supply Chain operations.
  • PM experience/track record
  • Project planning experience
  • Supervisory Experience.
  • Experience in the following:
    • Regulations
    • Design control processes
    • Design Quality
    • EU-MDR regulations and how to get submissions approved.

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