Process Development Engineer

This position works out of our Minnetonka, MN location, supporting our EP division. In Client’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As a Process Development Engineer, you will perform analyses to develop process technologies based on product design and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations.

What You’ll Work On:

• Execution of Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ)
• Write and release IQ reports
• Troubleshoot process equipment
• Assist in developing processes based on product specifications and in consideration to process and test method capabilities.
• Understand work environment issues (i.e. OSHA regulations, etc.).
  
  

Required Qualifications:

• B.S. in engineering
• 3 years experience in process development or manufacturing process engineering
• Experience developing and validating medical device manufacturing equipment, fixtures, and technologies with an emphasis on design for manufacturability (DFM) preferred.
• Experience performing installation qualifications (IQ).
  
  

Preferred Qualifications:

• Background in introducer/catheter processing