Manufacturing Engineer

electroCore, Inc.; Rockaway, Northern (NJ, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

electroCore, Inc. in New Jersey seeks a Manufacturing Leader to serve as a central resource for production support and sustaining engineering.

You will oversee QA compliance with FDA and ISO 13485, support NPIs transfers, and drive cost reductions while ensuring safety and productivity. Ideal candidates hold a Bachelor's in Manufacturing or Mechanical Engineering with 5+ years in ISO 13485 environments, and a Green Belt in Six Sigma or Lean; strong communication, Lean mindset, and SolidWorks

Qualifications

• Bachelor's degree in Manufacturing, Mechanical Engineering or equivalent with minimum +5 years in ISO 13485 production environment.
• Green Belt certification in Six Sigma and/or Lean Manufacturing preferred.

Responsibilities

• Ensure QA compliance within FDA and ISO 13485 standards and achieve production KPIs.
• Lead concurrent engineering with Engineering to transfer NPIs into manufacturing.
• Perform supplier qualifications, including external process capability studies.
• Perform IQ/OQ/PQ qualifications, potentially including PPQ validations.
• Review and revise manufacturing documentation (drawings, work instructions, batch records).
• Execute LEAN manufacturing techniques and foster a self-directed manufacturing environment.
• Identify manufacturing cost reductions and provide ROI justifications for changes.

Skills

Self-motivated

Multi-tasking

Strong communication

Strong analytical

Strong computer skills

SolidWorks

Production process understanding

FDA GMPs

Education

Bachelor's degree in Manufacturing or Mechanical Engineering

Tools

Six Sigma Green Belt

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.