High Level Mechanical Engineer

Responsibilities:

Advanced understanding of entire development process, including specification, documentation and quality assurance.
Provide innovative solutions concerning product design and development, and DFM (design for manufacture)

Leads activities related to test and evaluation of prototypes and finished medical devices.

Coordinate internal and external design program resources

Plans, executes, and functionally directs important engineering assignments that require independent judgment.

Generate ideas and solutions for new products as well as engineering support for current products.
Comply with regulatory requirements, including company design control procedures.
Review and analyze, including formal reports when necessary, such things as product concepts and needs, patents, sales and marketing plans, etc.
Assist with activities relating to the building, testing and evaluation of mechanical device systems.
Interface with vendors in component and process design.
Estimate project/product costs.
Provide engineering support to manufacturing and operations.

Perform mechanical, fluid, vibration, thermal, and reliability analyses to support new and existing product designs.

Fabricate prototypes utilizing internal and externally available resources.

Develop reliable manufacturing processes with associated fixtures and process control methods.

Develop test methods and conduct engineering feasibility testing of new product designs.

Write test protocols and reports in support of product and process verification/validation. Perform Risk Analysis including, Fault Tree Analysis (FTA), and Failure Mode and Effects Analysis (FMEA) activities
Understanding of system design, electronics, mechanical and software integration preferred.
Must be authorized to work in the United States on a full-time basis for any employer

Loading map ...

N

Road

1000 feet250 m

Requirements

BS in Mechanical Engineering; MS is preferred.

8 -10 years of experience in the design and development of high volume, high quality Medical Disposables, filters and devices.

Must have solid background in applicable manufacturing processes such as injection molding, thermoforming, extrusion and plastics assembly.

Knowledge of disposable medical device design requirements, sterilization methods and its effect on materials and packaging methods

Must have demonstrated proficiency with the use of Solidworks Design CAD tools.

Experience with finite element and analytical software packages required.

Prior medical device experience is required

Expertise in Design for Assembly and Design or Manufacturability

Ability to work independently as well as in a team oriented environment.

Effective communication skills (both orally and in writing) are required.

Project leadership skills and demonstrated experience in hands-on management of project teams.

Strong analytical engineering skills such as Finite Element Analysis, thermodynamics, Computation Fluid Dynamics.To find out more about Real Staffing please visit www.realstaffing.com