Medical Device Design Engineer - SolidWorks

 

 

ISG Resources’ management team has over 50 years experience in the Biomedical/ Automotive/ Manufacturing/Logistics industries. 

 

Our Atlanta, Georgia client has requested we research, identify and intro-duce a top grade candidate for their Medical Device manufacturing firm.  We are seeking a creative Product Design & Quality Engineer with 4-6 years experience in designing of new medical devices and modifications to current product designs   

 

The ideal candidate will be a key member of the engineering team with lead responsibilities for new product launches.  This position will also review, interpret validate, test and incorporate customer requirements into product specifications.

 

Responsibilities:

· Perform engineering analysis on OEM products

· Implement new technologies and processes to expand manufacturing capabilities

· Actively support compliance to FDA and ISO requirements

· Interface with customers and suppliers externally and interface with multiple disciplines internally

· Manage multiple concurrent projects with competing resources and timelines

· Perform R&D on new projects from initial customer concept meeting through production release

· Lead continuous improvement initiatives

· Equipment design and review with in-house tool maker.

· Product/equipment design, implementation and validation

· Write technical reports and documentation (i.e., Design History, Risk management,

Product Realization files, Mold Verifications, Product/Process Validations)

 

Requirements:

· BS in Mechanical Engineering or related discipline

· 5+ years related experience

· Knowledge of insert and injection molding products and processes

· Strong knowledge of engineering design principles, practices, and theories

· Strong knowledge of engineering design principles, practices, and theories

· Working knowledge of GMP, FDA, and ISO requirements

· Working knowledge of mechanical and hydraulic design principles

· Working knowledge of SolidWorks or similar 3D CAD applications

 

Competencies:

· Internal Collaborator

· Works Independently

· Results Oriented

· Responsible and effective Team Member

· Ownership of projects

· Technical Competence

 

Interested candidates should forward their resume to: 

 

BAdamek@isg-resources.com

 



Not all resumes will receive a reply!

Local Candidates preferred/relocation is not offered for this position.