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Senior Manufacturing/Process Engineer

Posted: 08/03/2022

This position, at Cook Advanced Technologies, involves developing and validating manufacturing processes that are used to produce device designs at a small scale and that can be scaled up as successful designs are transferred for commercialization.  The position involves collaborating with design engineers to develop designs that are readily manufactured.  The function will primarily be involved with projects in early research and development phases, undergoing initial or early clinical trials in both the US and OUS.
 

This position requires a technically sound engineer capable of driving a project to completion with minimal supervision.  A qualified candidate should be able to perform independent process development work utilizing all available tools and resources and communicate well with colleagues, vendors and customers.  Job functions may include:

  • Develop, refine and document manufacturing processes
  • Providing ongoing engineering support for pilot manufacturing operations
  • Collaborate with design engineers to refine design and translate to pilot production
  • Identifying resource needs for pilot production: personnel and facilities
  • Working with production coordinators and manufacturing personnel to create efficient processes and to maximize production yield
  • Analyze process risks and inefficiencies
  • Qualify manufacturing processes and validate when necessary
  • Ensures manufacturing efficiency by analyzing and planning work-flow, space requirements, and equipment layout
  • Assures product and process quality by designing, validating and documenting inspection and test methods
  • Provides manufacturing decision-making information by calculating production, labor, and material costs
  • Ensures production operators and technicians are adequately trained
  • Participate in or driving process risk management activities
  • Provide leadership and mentoring for technical and manufacturing personnel
  • Document activities in design history file
  • Work together on a team with project leaders, development engineers, physicians, clinical, regulatory and quality team members

 

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