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.