Engineering Program Director

Qualifications:

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  Bachelor or Master degree in Engineering or related field with 10+ years of experience in medical device development or contract manufacturing.

  
  


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  Direct experience taking a product from concept to commercialization including design controls, verification, validation, and manufacturing readiness.

  
  


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  Direct experience authoring, co-authoring, or substantially supporting 510(k) submissions in partnership with regulatory and quality teams.

  
  


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  Experience interfacing directly with customers in a CDMO or contract manufacturing environment managing multiple concurrent programs.

  
  


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  Strong understanding of regulatory and quality systems including ISO 13485, ISO 14971, and FDA design control requirements.

  
  


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  Experi...