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Manufacturing Engineer
Ref No.: 18-10686
Location: Jersey City, New Jersey
Position Type:Contract
  • 5+Yrs experience with product and process Risk assessment, Documentation
  • Minimum 3 years of hands-on experience working in the medical device field
  • Understand in-house SOPs related to Manufacturing Process Validation and GDP.
  • Ability to draft work instructions based on review of ongoing process workflows,
  • Hands-on experience working and understanding PFEMA and DFEMA for Medical products
  • Knowledge of ISO 13485, FDA documentation
  • Experience with the engineering design, analysis, execution and approval of manufacturing IQ, OQ and PQ protocols and reports.
  • Comfortable working with Microsoft Office
  • Comfortable working in a cGMP manufacturing floor for 5% of the time and 95% in front of a computer
  • Comfortable writing engineering documents and reports.