Process Engineer

• Review/author validation/qualification protocols and reports for the product, process, equipment, and software

• Hands-on development, qualification, and implementation of new production systems integrating mechanics, electronics, and software

• Support Operations on process validation and manufacturing process controls including:

-Developing validation strategies

-Evaluating existing processes and scale-up activities for process improvements and economy-of-scale efficiencies to improve cost-savings and product quality while managing technical and compliance risks

• Support production capacity improvements

• Support qualification of alternate supply sources or new vendors

• Support engineering investigations and root cause analysis

• Supports the regulatory submission process in compliance with all ISO, MDD/MDR, and FDA regulations and requirements

• Support in-process inspections by establishing/revising specifications and/or inspection methods.

• Support equipment calibration and preventative maintenance program

• Update and maintain proper Quality System records, reports, and statistics