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Mechanical Engineer

Location : Clifton NJ US 07013
Job Type : Direct
Reference Code : 21064-BZ1
Compensation : 80000.00 - 100000.00 USD/YEAR
Start Date : 06/07/2022
Hours : Full Time
Required Years of Experience : 6
Required Education : BS Mechanical Engineering
Travel : No
Relocation : No
Job Industry : Engineering

Job Description :


  • Permanent position for a Mechanical Engineer for design of medical devices and medical equipment, specifically for pneumatic design projects.

  • Interprets customer specifications to define requirements for mechanical designs.

  • Applies the 3D CAD system to create mechanical design and drawings.

  • Develops detailed fabrication and assembly drawings and performs tolerance analysis.

  • Develop prototypes for design evaluation.

  • Preparation Engineering Change Notices.

  • Generation / execution of Process Validation Protocols/Reports.

  • Preparation / Chairing Design Reviews including preparation / distribution of meeting minutes.

  • Troubleshoot and resolve design & processing issues.

  • Design documentation using electronic documentation systems.

  • Develops & execute design verification protocols and technical reports.


 


Required Qualifications :


  • BS Mechanical Engineering

  • Minimum 6 years experience with mechanical design.

  • Experience with Solidworks and/or Pro/ENGINEER

  • Experience in medical equipment / device design with particular experience in electromechanical, electro-pneumatic and pump design.

  • Knowledge in medical device industry regulations and practices - ISO 13485, ISO 7198 & GMP.

  • Design for Manufacturability and Assembly experience, DFM&A (cost/tooling/process considerations). 

  • Experience with design of molded plastic or cast parts, sheet metal, Pneumatics, and cabling.

  • Experience with Verification / Validation testing and and ability to create test documentation (protocols).

  • Experience with GMP and operating in a 21 CFR 820 compliant work environment.

  • Familiarity with dimensioning and tolerancing, thermal and structural analysis.


 


 



Contact: Bill Zukowsky


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