Engineer II, Mechanical

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

6d•$88,100 - $134,400•Onsite

About The Position

The Mechanical Engineer is responsible for mechanical design, testing, and documentation responsibilities in the development of new instrumentation and support of existing instrumentation for the biodefense, clinical and life-science markets. Design work will include the design of precision mechanisms and complex assemblies that include machined, molded and sheet-metal components.

Requirements

Bachelor’s degree in Mechanical Engineering
Minimum 5 years of relevant experience
Demonstrated CAD experience is required

Nice To Haves

Master’s degree in Mechanical or Industrial Engineering
Medical or scientific instrument design experience
Experience in an ISO cGMP environment
Knowledge of the design of injection molded components
Knowledge of the design of electromechanical systems
Demonstrated understanding of GD&T tolerancing practices
Solid knowledge of SolidWorks, I-DEAS, Pro/Engineer, or AutoCAD
Demonstrated ability to develop, integrate and validate systems, in a GMP, ISO or other regulated production environment
Working knowledge of the manufacture of FDA regulated devises

Responsibilities

Work within cross-functional teams to support the design and development of MSD instrumentation.
Design, prototype, test, and troubleshoot new and existing instrumentation designs.
Contribute to the development of specifications for new instrumentation.
Develop and execute test protocols for both informal and formal design testing.
Design, build, and test manufacturing test fixtures to support production of new instrumentation.
Prepare assembly and test procedures for new instrumentation designs.
Interact with outside vendors to source parts.
Perform design and development work in conformance with ISO and FDA cGMP processes.
Specific duties may vary depending upon department requirements.