Posted in Other 15 days ago.
The Mechanical Engineer III 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. The incumbent is responsible for leading the planning, documentation, prototyping and testing of designs.
DUTIES AND RESPONSIBILITIES:
* Work with cross-functional teamsto support design anddevelopment of instrumentation
* Lead the mechanical design, prototyping, testing, and troubleshooting of new instrumentation designs
* Contribute to the development of requirements and specifications for new instrumentation.
* Lead the development and implementation of test protocols for both informal and formal design testing
* Lead the planning, design, construction and testing of manufacturing test fixtures to support manufacturing of new instrumentation
* Lead the development of written assembly and test procedures for new instrumentation designs
* Interact with outside vendors and supplier quality departments to source and parts
* Perform design and development work in conformance with ISO and FDA cGMP processes
Lead the development of relevant design control documentation
Present designs, engineering issues, and solutions to senior engineering and compan management as required.
* Specific duties may vary depending upon department requirements
EXPERIENCE AND QUALIFICATIONS:
* Bachelor's degree in Mechanical Engineering. Master's degree in Mechanical Engineering or Industrial Engineering preferred
* Minimum of 10 years of relevant experiencepreferred
* Experience in an ISO cGMP environment required
* Medical or scientific instrument design experience preferred
* Demonstrated CAD experience is required
KNOWLEDGE, SKILLS AND ABILITIES:
*Strong knowledge of the design of injection molded components preferred
Strong knowledge of the design of electromechanical systems preferred
Proficiency and knowledge of GD&T tolerancing practices required
* Advanced understanding of manufacturing technologies including machining, molding and sheet metal processes
Working knowledge of the manufacture of FDA regulated devises is a plus
Proficiency with Solidworks, I-DEAS, Pro/Engineer or other comparable advanced CAD software
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
* Proficiency in MS Office suite
Demonstrated propensity to be creative, collaborative, proactive, and self-motivated in the execution and completion of assigned accountabilities.
Demonstrated ability to meet deadlines, manage processes through to completion and coordinate a high level of activity under a variety of conditions and constraints.
A wide degree of creativity and latitude is expected including the ability to multi-task in an environment with changing priorities
While performing the duties of this job, the individual is frequently required to sit and stand for long periods. The individual will occasionally be required to walk; use hands and arms 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 workplace.
This position is performed in a traditional production environment and/or light-manufacturing facility.