Injection Molding Sr Manufacturing Engineer

Description:

 The Manufacturing Engineer III supports new product Introduction and existing products improving productivity, efficiency and yield.  Leads assembly line and equipment qualifications and manufacturing process changes. Develop master validation plans and appropriate protocols and report. Creates and maintainsdocumentation to comply with FDA and ISO regulations.Provide technical support to existing products and processes using structured methods based on Lean Manufacturing and Six Sigma methodologies.

Key Responsibilities:

• Creates and maintain proper manufacturing documentation as SOP’s, Operator and process instructions, forms and reports.
• Assembly line incorporation based on lean manufacturing principles
• Assures ISO and FDA regulation compliance

• Responds to  CARS, NCR, and SCRs with definitive solutions that eliminate recurrence and promote process improvement.

• Interacts with customer to answer corrective actions, engineering changes and supplier change requests.
• Develops and execute cost reduction and continuous improvement projects applying Lean manufacturing and Six Sigma principles.
• Designs and implements fixtures and jigs to improve manufacturing operations (assembly, inspection, visual aids, etc)
• Identifies, structures and executes continuous improvement activities (Opex events), cost reduction initiatives and efficiency improvement projects.

Determine root cause analysis, and implement corrective and preventive action plans.Develop, write, and execute Validation Protocols (IQ/OQ/PQ), reports, internal audits, work instructions.Analyses Data (SPC, DOE,) to find causes of variation and address proper correction or improvement.

• Monitors KPI’s and overall performance of assembly lines and secondary operations to identify improvement opportunities.
• Reviews, maintain BOMs and routings up to date in accordance with improvements and modifications to new or existing processes.

Qualifications

• Bachelor’s degree in Engineering (Industrial, Manufacturing, Electro-Mechanical or equivalent)
• Hands on experience
• Experienced in MS office tools (Word, Excel, Powerpoint, Project etc.)

• Experience with CAD Software (Solid Works & AutoCAD) preferred.
• Experience with Data Analysis software  (Minitab)

• lean manufacturing and Six Sigma black belt certification or higher required

Requirements, Skills & Experience: