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Production Engineer, Medical Devices

Location : Caldwell NJ US 07006
Job Type : Temp/Contract
Reference Code : 20360-BZ1
Compensation : open - 35-40/h
Start Date : 11/02/2020
Hours : Full Time
Required Years of Experience : 2
Required Education : BS Biomedical, Mechanical or Manufacturing Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :


  • Contract position for a Production Engineer for medical device manufacturing.

  • Responsible for remediation activities such as reviewing production procedures, addressing deficiencies in documentation, and other improvements related to compliance issues.

  • Review production procedures, address deficiencies in documentation, and implement documentation changes as needed.

  • Documentation includes engineering specifications, engineering change notices (ECNs), manufacturing procedures, equipment registrations and other documentation.

  • Initiate Change Notices to document changes being implemented.

  • Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.

  • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (as applicable to the job function).


Required Qualifications :


  • BS Biomedical, Mechanical or Manufacturing Engineering 

  • Minimum 2-4 years of related experience with medical device manufacturing.

  • General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.

  • Experience with process and equipment validation and qualification.

  • Computer skills including, but not limited to: Microsoft Windows, Word, Excel.

  • Basic understanding of statistical analysis.



Contact: Bill Zukowsky


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