Engineer II, Mechanical

POSITION SUMMARY :

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.

DUTIES AND 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.

EXPERIENCE AND QUALIFICATIONS :

• Bachelor’s degree in Mechanical Engineering, Master’s degree in Mechanical or Industrial Engineering, preferred
• Minimum 5 years of relevant experience preferred
• Medical or scientific instrument design experience preferred
• Experience in an ISO cGMP environment preferred
• Demonstrated CAD experience is required

KNOWLEDGE, SKILLS AND ABILITIE S :

• Knowledge of the design of injection molded components desired
• Knowledge of the design of electromechanical systems desired
• Demonstrated understanding of GD&T tolerancing practices preferred
• Solid understanding of manufacturing technologies including machining, molding and sheet metal processes
• Strong engineering fundamentals and analytical background

o Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion

Excellent oral, written, and interpersonal communication skills

o Effectively communicate issues / problems and results that impact timelines, accuracy and reliability of project data

• Solid knowledge of Solidworks, I-DEAS, Pro / Engineer, or AutoCad is preferred
• Proficiency in MS Office suite
• A wide degree of creativity and latitude is expected including the ability to multi-task in an environment with changing priorities.
• Demonstrated ability to develop, integrate and validate systems, in a GMP, ISO or other regulated production environment is preferred
• Working knowledge of the manufacture of FDA regulated devises is a plus

PHYSICAL DEMANDS :

While performing the duties of this job, the individual is frequently required to sit and stand for long periods. The individual is occasionally required to walk;

use hands and fingers to operate, handle, or feel objects, tools, or controls; reach with hands and arms.

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT :

This position is performed in R&D, light-manufacturing, and engineering office environments.