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 ABILITIES

• 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.