Laser Marking (SME) Engineer

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Laser Marking SME Engineer for a 12 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

This position will be part of an R&D team focused on EU MDR compliance. This individual will be considered as a laser marking SME & will be responsible for developing the AIDC path forward for our clients Spine Division as a member of the EU MDR team.

Position Description (Principle Duties and Responsibilities)

• Designs, validates and will be in charge of Laser Marking updates on multiple Medical Device products.  
• Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety. 
• Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials. 
• Ability to define the project scope by evaluating product characteristics (i.e., materials, coatings, dimensional, region limitations, PREN, etc.) and supplier capabilities; identify worst-case materials & parts.
• Ability to use Mechanical engineering knowledge/skills to do a deep-dive review of other Divisions' capability studies and other testing for synergies.
• Ability to use Mechanical engineering knowledge/skills and technical writing skills for creation of Engineering Analysis documents.
• Ability to interface closely with our test lab to develop and execute capability studies. General test constructs discussed include the following (but not limited to):
  • Determine robustness of AIDC 2D barcode on various materials over a fixed period/re-use; determine the timeframe that the barcode on the part is readable/durable over product lifetime; determine limitations on geometry/material/surface finishes.
• Ability to partner with Sourcing Team to initiate conversations with suppliers on their AIDC 2D barcode capabilities. 
• Ability to research the appropriate AIDC 2D barcode reader required to comply with ISO29158 & Minimum Grade C standards.

Requirements

• Bachelor's degree; in engineering or applicable technical field (mechanical or biomedical preferred) (M.S. or/and Ph.D. in Engineering or related field welcomed)
• 4+ years' of medical device design and development experience 
• Proven track record of collaborating with others to design and develop high priority medical technologies, preferred
• Excellence. Dedication. Passion.