CAREERS

Senior Manufacturing Engineer

Purpose and Scope

The purpose of this role is to support manufacturing activities related to Monteris Disposable Devices.

Primary Organization Responsibilities

  • Lead daily manufacturing activities/support such as root cause analysis, , continuous improvement initiatives, resolving line down issues, equipment qualification, and execution of formal studies. 
  • Act as subject matter expert for disposable manufacturing lines and processes
  • Oversee transfer plan and execution of new manufacturing lines
  • Utilization of statistical methods to inform and drive data-based decisions around process improvements, validations, etc.
  • Serve as the voice of manufacturing and core team member on projects for new product development and quality initiatives.
  • Provide support into complaint investigations, CAPAs, non-conformance events, and any other disposable product related issues
  • Develop manufacturing processes, procedures, and associated process validations
  • Write test protocols, execute testing, analyze data, and write engineering reports.
  • Perform other duties as directed or assigned

Education/Experience

  • Bachelor’s degree in engineering or related field
  • 5+ years’ experience in medical device development, testing, quality, manufacturing, or other relevant discipline

Skills/Abilities

  • Possess strong organization, engineering, analytical and communication skills
  • CAD
  • Statistical knowledge and ability to create/analyze data within statistical based software
  • Possess the ability to be able to build product as required
  • Be extremely comfortable with accountability and being challenged to improve both their organization and the company’s performance against quality goals