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MECHANICAL ENGINEER

Mechanical Engineer with Medical Device/Regulated

Under routine supervision, the Mechanical Engineer is primarily responsible for the development of new products and or the enhancement of existing products. The role is involved in creating designs, modeling, and drafting utilizing a 3D CAD system. Other responsibilities include assisting in the development processes for Manufacturing, Quality Control, Regulatory, and Planning for their particular project.

Responsibilities:

• Designs, develops, and processes implants and instruments utilizing SolidWorks CAD software.
• Leads the development of new products and manufacturing processes and/or serves as a member of a project team.
• Directs the development of working prototype models to be used for project design evaluation.
• Generates protocols for testing and analyzing new and current products.
• Generates design assurance documentation for the project.
• Design History File (DHF) Develops quality control procedures and inspection methods.
• Initiates design changes relative to manufacturability while maintaining critical features of each product for in house manufacturing or vendors.
• Leads and/or serves on cross-functional product development teams responsible for new product development from concept through product launch.
• Provides technical input to marketing counterparts on the development of collateral marketing materials.
• Provides technical expertise to marketing and sales as to intent of design function.
• Provides technical experience to Regulatory Affairs to support FDA.

We are an EEO/AA employer and maintain a drug-free workplace.

Excellent salary and benefits.

Requirements:

• BSBE
• SolidWorks
• Familiar with FDA regulations
• Has designed medical devices, particularly orthopedic or dealing with the spine.
  
• Local Candidate Preferred.
  

For immediate consideration, please forward a copy of your current resume to info@profrecruiters.com referencing job # or a link to this job.

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