Program Manager - NPI

Danvers, MA

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Job Description

Job Description:

The Program Manager for NPI will lead a team of Manufacturing Engineers to ensure the smooth and timely transition of new products from feasibility into stable production.

 

Principle Duties and Responsibilities:

  • Organize the team around standardized best practices for project management, including schedule development, resource and budget estimates, requirements generation, cost/benefit analyses, design and development milestones, priority and task management, and meeting facilitation.
  • Manage direct reports including establishing goals and objectives, prioritizing, assigning and directing work, and appraising performance.
  • Mentor team in areas of engineering expertise, constantly moving the team towards improvements in technical skills and system knowledge.
  • Work in cross-functional teams that span global operations. 
  • Contribute early in the development process, influencing the product specification to achieve the best quality, cost and cycle time.
  • Lead design for manufacturing (DFM) reviews to ensure producibility, inspectability, testability, maintainability and repairability.
  • Assist in prototype and pilot builds, document the build process with work instructions, define and implement new manufacturing technologies.
  • Qualify and optimize processes and tooling via IQ/OQ/PQ, gauge R&R studies, process capability studies and designs of experiments.
  • Partner with design engineering to develop supplier specifications with strong emphasis on DFM.
  • Define and establish Lean manufacturing methods, processes, and tools for new products. Establish process controls and opportunities for Poka Yoke (mistake proofing of products and mistake proof processes). 




Skills/Requirements

Skills/Requirements
 

  • Bachelors or Masters Degree in Mechanical or Manufacturing Engineering or applicable scientific field.  
  • 10+ years relevant experience in Manufacturing Engineering (medical device experience preferred).
  • Ability to work well in team environment with excellent written and verbal communication skills.
  • Expertise in: polymer processing, mold design best practices, metrology, GR&R and GD&T.
  • Hands on capability with good knowledge of manual and automated miniature component assembly techniques.
  • Skills/experience with statistics, statistical tools/techniques.
  • Desirable skills:
  • LEAN Manufacturing certification and proven track record of implementation
  • Six Sigma Green Belt (Black Belt preferred) certification
  • Experience developing products under FDA control
  • Position requires up to 25% travel – US & EU  #LI-LG1

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