Manufacturing Engineer

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

Description

This position is responsible for leading as a central resource for Manufacturing and assists with day-to-day

production support and improvements. Responsible for managing all activities for sustaining engineering

philosophy, productivity and safety advantages, environment and implementation.

• Ensure QA compliance within regulatory standards such as FDA and ISO 13485, while achieving production Key Performance Indicators (KPIs).
• Lead concurrent engineering practices with Engineering to successfully transfer New Product Introductions (NPIs) within manufacturing.
• Perform/complete supplier qualifications, which includes, but not limited external process capabilities studies.
• Perform/complete process IQ/OQ/PQ qualifications, which may include PPQ validations.
• Review, create, revise, etc. manufacturing documentation (i.e. drawings, Work Instructions, Batch Records).
• Execute LEAN manufacturing techniques and principles, but not limited to:
• Must be a team player and understand motivating team members into a LEAN environment.
• Facilitate a "self-directed" manufacturing environment.
• Minor design/development of manufacturing fixtures and equipment.
• Identify manufacturing cost reductions and provide ROI justifications for change.

Requirements

Bachelor's degree in Manufacturing, Mechanical Engineering, or equivalent with minimum of +5 years of proven

experience in ISO 13485 production environment is required. Green Belt certification in Six Sigma and/or Lean

Manufacturing preferred.

Required Skills:

• Self-motivated to accomplish goals and objectives with little supervision.
• Multi-tasking skills are required to manage multiple projects and various project activities.
• Strong communication, presentation, and interpersonal skills are needed to interact with all areas of business and internal/external customers.
• Strong analytical and technical skills are needed for all product support activities.
• Strong computer skills, including knowledge of SolidWorks required.
• Ability to understand production processes and should be aware about the product operations.
• Ability to follow all the internal, FDA's GMPs, and ISO quality standards guidelines strictly.