Senior Project Engineer (II or III)

New Brunswick, New Jersey | Engineering

Project Engineer – Senior (II or III) Level

 

Our client is a highly successful, contract manufacturer in the medical device space. The Project Engineer is responsible for the management, development and validation of products and processes of a complex nature. Projects may include components, subassemblies, or complete medical device assemblies, the planning of their processes, resource demand planning and budgeting.

 

Your leadership skills are critical to your success as you will lead teams that may include internal or external engineering and operations resources; in-depth interactions across the organization and in contact with clients are common.

 

RESPONSIBILITIES:

  • Directs large, complex projects of multi-layered Medical Devices from components to complete assemblies
  • Leads teams of internal and external resources to develop, design, and validate new products
  • Interacts across the internal organizational chart and with high-level external stakeholders to communicate everything from tasks to strategy and including status
  • Based upon an in-depth understanding of customer requirements (inputs), develops schedules, budget, forecasts and resource demands, executing the plan for completion of the project
  • Directs all of the activities related to V&V
  • Is responsible for the smooth and efficient transfer of development projects to production
  • Accountabilities include material, equipment, staff and contractor selection
  • Centrally responsible for all documentation including all protocols, test results, PFMEA’s, control plans, capabilities studies, Design Control and PM
  • Hands-on execution of IQ/OQ/PQ, engineering studies utilizing DOE, SPC and other tools as required by the customer
  • Has in-depth knowledge of GD&T symbols, interpretation and application, developing inspection methods for critical dimensions and ensuring measurement capability
  • Champions process improvement (e.g. Lean/Six Sigma)
  • Contributes to the selection of new equipment

REQUIREMENTS:

  1. Bachelor’s degree in Engineering or other technical discipline
  2. 7 years of relevant project management experience
  3. Exceptional organizational skills including experience with tools like Microsoft Project
  4. Strong blueprint reading background including in-depth knowledge of GD&T, SPC, GR&R and DOE
  5. Experience in Medical Device manufacturing; including injection molding and or metal fabrication
  6. Demonstrable experience in Root Cause analysis and the effective, timely implementation of CAPA
  7. Experienced with, or prefer certifications in, Lean/Six Sigma
  8. Ability to manage multiple projects
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