Laser Marking (SME) Engineer - Impact Business Group

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.

Contract positions

Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment. 

Permanent placed employees

Paid by and qualify for benefits in accordance with the policies of the hiring company. 

Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.

Internal Positions

We have several internal positions at iMPact that we are hiring for. Please view our internal positions here.

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