Principal Mechanical Engineer , Medical Adhesives

• Directly responsible for development and design of innovative delivery system platforms to support market needs across an array of products, including but not limited to:

                    1.      Planning and administration of delivery system design efforts through all 

                       phases of product development (concept to full commercialization);

                    2.      Prototype product design, development and testing;

                    3.      Pre-clinical and clinical product evaluations;

                    4.      Commercial and industrial design integration; and

                    5.      Design Verification & Validation protocol development, testing and report writing.

• Leads designated multi-functional product development teams.


• Conducts design reviews and performs failure mode and effects analysis.


• Participates as Principal Mechanical Engineer in designated development teams.


• Interfaces with Manufacturing in the development of production assembly processes to support commercialization of design concepts.


• Establishes requirements necessary to maintain FDA, ISO and CMDR compliance.


• Performs special projects and other duties as assigned.

Education/ Expertise

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  Bachelor of Science degree in Mechanical Engineering (B.S.M.E.).
  
  


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  Minimum of ten (10) years experience in Medical Device Design in New Product Development.
  
  


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  Expertise in developing New Technology (Revolutionary development, not Evolutionary development), from product conception through to commercialization, bringing a brand-new platform to market for the company.
  
  


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  Extensive experience with all aspects of the product development cycle including developing concepts, feasibility studies, project planning, prototype design, documentation, DOE, testing, analysis and reporting.
  
  


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  Proven track record of success in developing innovative, technologically advanced devices.
  
  


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  Proficient in Solidworks 3D modeling or expertise in Pro-Engineer with some experience in Solidworks; expertise in Mathematica, Matlab, and/or Labview a plus.
  
  


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  Experience developing experimental studies, DOE, and analysis of experimental result
  
  


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  Experience with injection molded parts design.
  
  

Education, Experience, & Skills (continued)

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  First-hand knowledge of materials and fabrication techniques.
  
  


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  Experience with ISO / FDA Quality System Requirements and guidelines.
  
  


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  Experience with small scale fluidics, fluid dynamics and/or Computational Fluid Dynamics (CFD) software (such as STAR-CCM+) and analysis background is a plus.
  
  


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  Experience with FEA a plus.
  
  


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  Experience with small gas-assist pressure-delivery devices, preferably for hand-held medical devices and/or medical adhesive delivery systems is preferred.
  
  


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  General knowledge of MS Office, PowerPoint, Excel.
  
  


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  Strong organizational and communication skills.
  
  

Abilities/Attributes

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  Highly analytical and hands-on. 
  
  


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  Detail-oriented.
  
  


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  Ability to assume complete responsibility (take complete ownership).
  
  


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  Results-oriented, good at setting priorities and staying focused.
  
  


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  Hard-working, driven, self-starter, self-motivated, a ‘can-do’ / ‘whatever it takes’ attitude.
  
  


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  A team player with a positive attitude.
  
  


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  Strategic focus towards solution of problems.