Mechanical Design Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Mechanical Design Engineer for a 12 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Responsible for the design, modeling, development and testing of a machine, structure or system. Develops functional requirements. Understands and applies standard engineering principles. Creates simulations and prototypes to evaluate preliminary designs and test how a machine, structure or system operates. Designs and tests components, and integrates components to produce final product. Monitors quality of products and controls the efficiency of processes. Evaluates a design' s overall effectiveness, cost, reliability, and safety. Investigates root causes of failures to maintain quality and recommend improvements.
Responsible for initiating change documents (created in the Design & Development phase) for validating, verifying designs to get them routed and approved by Engineers and Managers.
Create packages, labels and part markings to uniquely identify the products sold in the market that adhere to strict FDA regulations.
Maintain a record of the Design Inputs and Outputs which makes up a Design History File
EXPECTATIONS AFTER TRAINING:
o Review of existing DHF / DMR information and starting on performing a full layout to assess the existing prints vs the existing design.
o Hit the ground running as a Pro-E / CAD specialist.
3 years experience in Pro-E / Creo
Perform intensive research to transform the Design Inputs & existing prints into 3D models/drawings to determine the shape and size of the devices which conform to the internal Design Control Requirements per FDA requirements.
Geometrically evaluate and document the different interactions between the Implants and Instruments. (GD&T).
Perform verification and validation to the designs to ensure their structural integrity. (Strength, Temperature Effects, Material Properties, Vibrations, Fluid Dynamics, Durability, Manufacturing Procedures etc.)
Communicate the design intent with the supplier and manufacturers to manufacture the devices.
Analyze User Needs and write Design Inputs to ensure part functionality. Evaluate the Designs using Anatomic Data that conform to the existing procedures and standards. (ANSI, ASME, FDA)
Familiarity with MS Office applications (Excel, Word, etc)