Mechanical Engineer

Domain: Medical Devices Mechanical Circulatory Support (Heart Failure R&D)

Requirements:

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  Bachelor s degree in Mechanical Engineering or related field.

  
  


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  6+ years of mechanical design experience in the medical device industry.

  
  


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  Hands-on experience with INSTRON-based mechanical testing.

  
  


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  Strong proficiency in SolidWorks and GD&T.

  
  


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  Experience with FEA and design for reliability.

  
  


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  Background working in regulated environments with strong technical documentation skills.

  
  

Key Responsibilities:

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  Design and develop mechanical components and subsystems for LVAD products.

  
  


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  Perform mechanical testing (compression/tensile) using INSTRON or similar systems.

  
  


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  Conduct engineering analysis, including FEA (and CFD where applicable).

  
  


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  Create detailed CAD models and drawings (SolidWorks, GD&T).

  
  


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  Lead design reviews, risk assessments (FMEA), and verification/validation activities.

  
  


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  Collaborate with cross-functional R&D, manufacturing, quality, and supplier teams.

  
  


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  Ensure compliance with FDA and ISO 13485 standards.

  
  

Benefits:

• The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable).