Manufacturing Engineer: NPI & Lean GMP/ISO Expert

ElectroCore Inc; Rockaway Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

ElectroCore Inc. is seeking a Manufacturing Engineer in New Jersey to lead as a central resource for manufacturing and support day-to-day production improvements. The role focuses on sustaining engineering, LEAN practices, and ensuring compliance with FDA and ISO 13485 standards.

You will drive concurrent engineering with Engineering for NPIs, perform IQ/OQ/PQ qualifications, and manage manufacturing documentation while seeking cost reductions and ROI justifications.

Qualifications

• Bachelor's degree in Manufacturing, Mechanical Engineering, or equivalent.
• +5 years of experience in ISO 13485 production environment.

Responsibilities

• Lead as central resource for Manufacturing and assist day-to-day production support and improvements.
• Manage activities for sustaining engineering philosophy, productivity and safety.
• Lead concurrent engineering with Engineering to transfer NPIs within manufacturing.
• Perform supplier qualifications including external process capabilities studies.
• Perform IQ/OQ/PQ qualifications (may include PPQ validations).
• Review and update manufacturing documentation (drawings, work instructions, batch records).
• Apply LEAN manufacturing techniques and foster a self-directed environment.
• Possibly design/develop manufacturing fixtures and equipment.
• Identify manufacturing cost reductions with ROI justifications.

Skills

Self-motivation

Multi-tasking

Communication skills

Analytical skills

Lean manufacturing

Production processes understanding

FDA GMPs knowledge

ISO quality standards

Education

Bachelor's degree in Manufacturing or Mechanical Engineering

Tools

SolidWorks

Job description

ElectroCore Inc. is seeking a Manufacturing Engineer in New Jersey to lead as a central resource for manufacturing and support day-to-day production improvements. The role focuses on sustaining engineering, LEAN practices, and ensuring compliance with FDA and ISO 13485 standards.

You will drive concurrent engineering with Engineering for NPIs, perform IQ/OQ/PQ qualifications, and manage manufacturing documentation while seeking cost reductions and ROI justifications.