Job Summary

Project Engineer

  • Location:
    Mahwah, New Jersey
  • Job reference:
    US_EN_3_106027_317847
  • Category:
    Engineering Management
  • Contract Type:
    Contract/Temporary





A Project Engineer job in Mahwah, NJ is currently available courtesy of Modis Engineering. The systems engineer will lead an effort to transfer the Design History File of a medical device to the internal quality system. The engineer will lead cross-functional teams that will focus on reviewing deliverables for compliance to quality and regulatory requirements. The role requires an individual with strong organization and communication skills, who can effectively interface with both technical and non-technical personnel.





Project Engineer job responsibilities include:

Develop and implement a project plan that outlines the transfer efforts
Work with cross-functional teams, in a leadership role, to ensure the completion of the DHF transfer to the agreed upon scope and timeline.
Review deliverables to determine their compliance to quality and regulatory requirements
Provide weekly updates to Management detailing the progress of the project, and identifying any issues that must be escalated
Excellent problem-solving, design, and technical skills
Experience in leading tasks or small projects by utilizing PMI principles\
Working knowledge of FDA and International Standards requirements as related to capital equipment
Medical Device experience including thorough understanding of Design Control and Risk Management.


QUALIFICATIONS:



BS in Engineering with 5+ years of medical device experience
MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 3+ years of medical device experience
Build Quality into all aspects of work.
Experience with Requirements Management Tools (such as CaliberRM)
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations.


Must be able to comply with U.S. and Worldwide medical device regulations.
Attend the provided Quality & Compliance training.
Adopt the “Beyond Compliance Quality Culture” in the work environment.
Must practice verbatim compliance with corporate Quality and Regulatory procedures.
Must be competent with the Customer complaint reporting procedures.
Must be able to promptly report any non-compliance issues to Chief QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.
Must be competent with 21 CFR 820, 801, 803,806 and any other applicable federal regulations, and Quality standards.
Must not be DE-Barred by FDA for work in any Medical Device or Pharmaceutical business.


If you are interested in Project Engineer job in Mahwah NJ then please click “APPLY NOW”. For other opportunities available at Modis Engineering go to www.modis.com. If you have questions about the position, please contact Heather Bennett at heather.bennett@modis.com or at 732-452-0438





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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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