Senior NPI Engineer

**Purpose Statement:**The role of the NPI Engineer is to initiate and provide guidance to the design, development, troubleshooting, and optimization of manufacturing and supporting processes for new product, using classical manufacturing engineering skills.  An NPI Engineer has a high degree of knowledge and understanding of one or more critical manufacturing processes.

Key Job Accountabilities:

• Execute and monitor new product introduction builds to drive improvements.
• Deliver world class user experience by establishing optimal manufacturing solutions.
• Publish progress reports on product readiness to stakeholders.

Education/Experience Qualifications:

• Bachelor’s Degree with 6 - 8 years of related experience is preferred. An equivalent combination of education and/or experience will be considered.

Key Qualifications & Requirements:

• Medical background for Class 3 FDA
• Experience in designing validation protocols (IQ, OQ, and PQ) for new NPIs
• Knowledge of cleanroom environments and sterilization processes
• PCBA and HLA experience
• Strong mechanical engineering background
• Experience in the product lifecycle, including APQP design
• Ability to serve as the primary customer interface for technical queries