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Manufacturing Engineer

NextPhase Medical Devices LLC is a fast growing, contract manufacturer of single- use disposable medical devices.  Headquartered in Waldwick, NJ, we also have manufacturing facilities in Rochester, NH and Tijuana, Mexico.

The Manufacturing Engineer is primarily responsible for developing processes for the transfer of new products into production.  Applying Lean principles, the Manufacturing Engineer is a key team member in the identification and realization of process efficiency improvements and cost reductions.  Production at NextPhase occurs in Class 7 & 8 Clean Rooms and requires proper gowning including hair/beard and shoe coverings, gloves and gowns be worn at all times while in the Clean Rooms.  The Manufacturing Engineer will spend much of their time working in the Clean Rooms in partnership with the Production.

Responsibilities:

 Design, create, test and document measurement and assembly fixtures.

  • Analyze and plan workflow, equipment placement and space requirements for new production layouts and improved efficiency of existing production.
  • Develop detailed instructions under process development for translation into working assembly procedures.
  • Lead and compose a cross-functional Process Failure Mode and Effect Analysis (pFMEA).
  • Effectively train production assemblers using drawings, specifications, and Assembly Procedures (AP’s).
  • Conduct multi-factorial design of Experiments, design and execute Process Validations, and present results demonstrating process capabilities.
  • Provide daily support to Production to ensure safe and efficient operations.
  • Define and perform preventative maintenance and repairs as needed.
  • Assist New Product Development engineers in the design of basic fixtures for assembly, such as holding fixtures, cutters, and go/no-go gauges.

Skills & Experience Required:

  •  BS in Mechanical, Manufacturing or related Engineering discipline preferred
  • 5+ years of production support and process development engineering experience in medical device field
  • Familiarity and prior working experience under ISO 13485:2016, ISO 14971:2007 and 21CFR Section 820 (FDA QSR)
  • Ability to read and interpret product and component 2D drawings, equipment schematics (electrical, pneumatic) and have a basic understanding of GD&T
  • Basic understanding of statistics and the ability to conduct statistical analysis with statistical software, Minitab preferred
  • Experience using Microsoft Office, including Word, Excel, PowerPoint and Outlook

 

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