Project Manager, Manufacturing Engineering

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Location: Irvine, CA US
Job Category: Engineering
Position Description
Project Manager, Manufacturing Engineering

As a Project Manager for Manufacturing Engineering, you will oversee the execution of manufacturing programs and/or projects consisting of single or multiple projects and/or programs.

In this role you will lead the development and execution of integrated project plans relevant to the deliverables, ensuring alignment across relevant functions and a smooth transition among pipeline stages. As well as manage multiple projects across several departments while influencing project decisions in coordination with Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics timelines.

In particular you can expect to:

  • Work within the constraints of budget, schedule, and scope, while managing risk, and ensuring adherence to established processes and methodologies.
  • Drive manufacturing engineering programs through project completion within timeline, quality, and budgetary limits.
  • Collaborate with a broad cross functional team to deliver on project plans.
  • Identify advanced implications/conclusions from the logical analysis of a complex situation or issue.
  • Apply comprehensive understanding of concepts within own technical areas to design relatively advanced solutions; demonstrate understanding of key business drivers.
  • Develop project plans and track execution and suggest alternatives to improve schedules.
  • Question current methods while evaluating broad implications, to develop practical improvements; focuses on achieving goals rather than a fear of failure.
  • Approach issues from multiple perspectives and collaborate with internal/external customers in generating creative, effective and practical solutions.
  • Lead and integrate cross-functional teams and manage deliverables in a matrix organization.
  • Identify and implement solutions to improve tracking, planning, and collaboration.

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company‚Äôs short-term and long-term success
  • Work closely with leadership across the organization
  • Grow your role as you see fit
  • Learn everything there is to know about respiratory medical device manufacturing
  • Create an inspiring workplace

To be successful, you will need:

  • Minimum of 10 years related work experience required; medical device manufacturing.
  • Ability to gain cooperation of others and effectively facilitate cross-functional meetings and discussions.
  • PMP Certification a plus
  • Manufacturing  transfer of product lines and validation 
  • Ensure effective, accurate and timely communication across functional areas.
  • Serve as a primary point of contact for management regarding progress and goals.
  • Ability to work with team leaders to identify and resolve any team and individual performance issues.
  • Bring a broadened business perspective to each project through an understanding of the inner-workings of Marketing, Quality, R&D, Finance, Regulatory, Manufacturing, Clinical, Medical Affairs, and Operations.
  • Create and maintain schedules that predict and meet milestones to track progress.
  • Review analyses of activities, costs, operations, and forecast data to determine program progress toward stated goals and objectives. Perform Risk Analyses: identify cost, ROI, manpower, overrun, margins, and scope-creep.
  • Ensure engineering disciplines are followed to ensure design output meets design input, and are successfully transferred to manufacturing products.
  • Confer with Senior Management to review progress and discuss required changes in objectives resulting from current status and conditions.
  • Working knowledge of the design control process.


  • Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering or related field required; or equivalent work class experience.

Some Logistics:

  • Location:  The current office is based in Yorba Linda however we be moving to the Irvine area.

Irvine, CA

Full time
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