New Product Introduction/NPI Reconstructive Sports Med

Warsaw, Indiana, United States

Posted on 03/14/2019 by Morisey-Dart Group


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Position Details

Type:

Permanent

Industry:

Healthcare / Medical Devices

Function:

Manufacturing / Production

Job Level:

Experienced Professional (Non-Manager)

Education:

Bachelor's Degree

Salary:

$80,000-$90,000

Reference ID:

2706

New Product Introduction/NPI Reconstructive Sports Medicine Products

Great companies are always looking to improve process and enhance outcomes. Our client is adding a New Product Introduction/NPI Engineer to the team.

This opportunity could change the trajectory of your career! If you are a creative problem solver and have background in medical textiles.

Our client manufactures medical textiles for tissue to tissue or tissue to bone repairs. They are a world-wide leader in design and delivery in this marketplace.

This is a critical fill and interviews will be scheduled immediately. Those chosen will have competitive salaries, bonus, solid benefits including healthcare, 401k, relocation assistance, and more. This client promotes from within and recognizes those who do their jobs well.

Responsibilities:

  • Continuous improvement in processes.
  • Communications to upper management
  • Conducts Management Review process in accordance with ISO standards.
  • Working knowledge of standards and regulations ISO 13485, FDA 21 CFR Part 820
  • Understanding of IO/OQ/PQ
  • Able to interpret technical drawings, blueprints, specifications, illustrations, and written documents
  • Validation representative for audits requirements (FDA, ISO)

Requirements:

  • BS in Engineering, Manufacturing, Mechanical, Biomedical
  • 5+ years in medical device or pharma (sterility assurance a plus)
  • Regulatory Compliance experience ISO13485 IQ/OQ/PQ
  • Experience in injection molding
  • Documenting and reporting the analysis of test results
  • Problem solver with strong written and verbal communication
  • Provide critical analysis to upper management
  • Review SOP’s and recommend improvements
  • Experience standards and regulations ISO 13485, FDA 21 CFR Part 820 also an understanding of ISO 11135, ISO 17665, ISO 11137, ISO 14644,
  • Strong computer skills, including the MS Office suite and MS Project.
  • Interpret technical drawings, blueprints, specifications, illustrations, and written documents
  • Detail oriented, self-motivated and a team player

 



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