The person in this position is responsible for approving new products and design changes in accordance with customer needs and regulatory requirements. The Engineering Manager is also responsible for assisting in customer complaint investigations and initiating corrective / preventative action. Other duties include, but are not limited to:

  • Provides leadership to Engineering staff and manages assignment of responsibilities
  • Manages customer product inquiries, product changes, and new product development
  • Develops procedures to be compliant with regulatory requirements
  • Reviews and approves Document Change Orders (DCO)
  • Evaluates design or manufacturing problems and initiates process improvements
  • Writes process validation protocols and results
  • Assists in investigating and answering customer complaints
  • Reviews and approves part specifications
  • Approves new drawings and BOM’s
  • Estimates and initiates solutions to reduce product costs

Qualified candidates must possess a Bachelor of Science degree in Engineering with at least four years of relevant work experience. Understanding of ISO 13485 and FDA medical device regulations required. Strong communication skills and computer proficiency necessary, including Microsoft Office and CAD. Must possess the ability to effectively delegate, motivate others, and manage all functions of the engineering department.

This position is located in Dubuque, Iowa.  Candidates must be authorized to work in the United States. Employer will not sponsor applicants for work visas.

 

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