KEY
RESPONSIBILITIES

The
Manufacturing Engineer will be responsible for the development and validation of
manual and automated assembly processes for disposable medical
devices.

Areas of
specific responsibility and attention include:

• Develop manufacturing processes in order to fulfill the product design
  intent
  
• Specify equipment capable of performing needed processes,
  within required tolerances.
  
• Develop process parameters through design of experiments or
  other techniques to define a robust process window capable of
  reproducing results with a low degree of variation.
  
• Develop instructions for assembly processes, machine
  operation, maintenance and calibration.
  
• Develop protocols for validation of processes; installation,
  operational, and process qualifications.
  
• Manage projects involving off-site manufacturing or vendor
  management.
  
• Train production personnel on new processes and
  changes.
  
• Trouble shoot process and equipment issues affecting product
  quality.

EXPERIENCE

• Proven track record of process development and validation,
  bringing disposable, sterile medical devices into production.
  
• 3 to 5 years experience developing process documentation
  compliant with GMP and ISO 13485 standards
• Understands specifications in drawings and blueprints.
  
• Translates product specifications into manufacturing
  requirements.
  
• Specifies equipment capable of meeting manufacturing
  requirements.
  
• Design fixturing and tooling to support manufacturing
  processes and testing.
  
• Specifies testing requirements and methods to test product and
  process outputs.
  
• Trouble shooting equipment and process
  issues.
• Understands and applies basic uses of statistics in the
  manufacturing environment including design of experiments, process capability
  and control charting.

EDUCATION

BS in a
Mechanical, Manufacturing or related Engineering field is required.