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Mechanical Engineer

Location : Upper Saddle River NJ US 07458
Job Type : Temp/Contract
Reference Code : 20410-BZ1
Compensation : open - 35-45/h
Start Date : 01/12/2021
Hours : Full Time
Required Years of Experience : 1-2
Required Education : BS Mechanical Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Contract position for a Mechanical Engineer for EU MDRpProject support creating Technical Documents for medical devices.

  • Products will include implantable devices and instruments.

  • Position is part of an R&D team focused on EUMDR compliance.

  • Review and create the Technical Files as part of the EUMDR team.

  • Review existing DHFs and translate the specifications related to design, verification, validation and standards into the new Technical Files.

  • Use CAD (Pro/ENGINEER) to modify drawings as part of Change Control to meet changes such as identification and design updates. 

  • Use of mechanical engineering knowledge/skills to interpret design history file (DHF) documents with expertise in medical device. 

  • Use mechanical engineering knowledge and technical writing for creation of Engineering Analysis documents. 

  • Support for product testing within the internal lab as needed. 

  • All work will be done using Teams/Sharepoint style collaboration sites. 



Required Qualifications :

  • BS Mechanical Engineering

  • Minimum 1-2 years experience with medical device design.

  • Experience with Pro/ENGNIEER.

  • Attention to detail and application of sound engineering practices to ensure compliance of files to meet the EUMDR compliance standards.

  • Experience with DHFs and Change Controls.


Contact: Bill Zukowsky

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