Principal Process Development Engineer

As part of a multidisciplinary process development engineering team the Process Development Engineer will be responsible for engineering support in the definition, design, process development, and production transfer of a wide variety of medical devices. This role includes collaborating with internal engineers, operations, and key client stakeholders.

DUTIES AND RESPONSIBILITIES:

• Identify technologies that meet the manufacturing needs of new product development programs


• Define design criteria and author associated documentation including User Requirements Specifications and Equipment Specifications for highly automated equipment


• Oversee vendor design and fabrication of automated manufacturing equipment


• Lead the definition and execution of the Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and process characterization.


• Represent the organization as a primary ...