Manufacturing Engineer - NPI, Lean & GMP Leader

Socket.dev; Rockaway (NJ); On-site; USD 80,000 - 115,000; Full time

Job summary

Socket.dev is seeking a manufacturing engineer to lead as a central resource for production support and improvements. You will ensure QA compliance under FDA and ISO 13485, while driving KPI targets and LEAN initiatives.

The role collaborates with Engineering for NPI transfers, conducts supplier and IQ/OQ/PQ qualifications, and maintains manufacturing documents. Strong cross-functional communication is essential.

Qualifications

• Bachelor's degree in Manufacturing or Mechanical Engineering and minimum 5 years in ISO 13485 production environments.
• Green Belt Six Sigma or Lean Manufacturing certification preferred.
• Experience leading manufacturing improvements and NPI transfers within regulated environments.

Responsibilities

• Lead as central resource for Manufacturing, supporting production and improvements.
• Ensure QA compliance with FDA and ISO 13485 while achieving KPIs.
• Lead concurrent engineering with Engineering to transfer NPIs into manufacturing.
• Perform supplier qualifications and process IQ/OQ/PQ qualifications (may include PPQ).
• Review and update manufacturing documentation (drawings, Work Instructions, Batch Records).
• Apply LEAN principles to create a self-directed manufacturing environment.
• Assist in design/development of fixtures and equipment and identify cost reductions with ROI justifications.

Skills

Self-motivated

Multitasking

Communication

Analytical thinking

Product/process knowledge

Production operations

FDA GMPs & ISO 13485 awareness

Education

Bachelor's degree in Manufacturing or Mechanical Engineering

Green Belt Six Sigma Certification

Tools

SolidWorks

Job description

Socket.dev is seeking a manufacturing engineer to lead as a central resource for production support and improvements. You will ensure QA compliance under FDA and ISO 13485, while driving KPI targets and LEAN initiatives.

The role collaborates with Engineering for NPI transfers, conducts supplier and IQ/OQ/PQ qualifications, and maintains manufacturing documents. Strong cross-functional communication is essential.