Manufacturing Engineer

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

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.