Insulet

Medical Device Manufacturing

StaffManufacturingEngineer

gelang patah, johor, malaysia FULL TIME
The Brief

“Staff Manufacturing Engineer at Insulet. Skills: Automation equipment, Manufacturing engineering, Process improvements, Root cause investigations. Manage automation equipment. Drive product improvements”

What You'll Achieve.

Machine up time KPIs; Process yield KPIs; Efficiency KPIs; Best Quality; Highest efficiency; Highest customer service; Lowest cost; Yield monitoring; Equipment uptime monitoring; Ensure KPIs are at or above target

Industry & Context.

Medical Device Manufacturing
Problems you'll solve

Root cause investigations; Structured problem solving tools; Problem Solving; Decision Making; Analyze product; Mechanical engineering methods; Fundamental physics

Eligibility Requirements

Travel to key suppliers

What They're Looking For.

Must Have

Mechanical analysis skills, Analyze product using mechanical engineering methods, Interpret mechanical properties of material, cGMP compliant environment, Operate within FDA guidelines

Nice to Have

Microsoft Office tools, Microsoft Excel, Data Analysis Skills, Minitab, JMP, Solidworks, Drafting skills, Troubleshoot mechanical equipment, Assembly of molded components, Structured problem solving tools, Project management skills, Decision Making, Communication Skills, Work Organization, Problem Solving, Initiative, Planning Skills, Perseverance

What You'll Do.

Manage automation equipment

Drive product improvements

Drive process improvements

Manage automation suppliers

Deliver machine improvements

Maintain cGMP environment

Operate within FDA guidelines

Generate validation protocols

Coordinate validation execution

Write validation reports

Author Engineering Change Orders

Implement Engineering Change Orders

Design manufacturing fixtures

Coordinate fixture construction

Coordinate fixture validation

Support project phases

Implement into manufacturing

Support manufacturing

Use problem solving tools

Carry out investigations

Implement corrective actions

Implement preventive actions

Monitor yield information

Monitor equipment uptime

Report yield information

Report uptime information

Support new production introduction

Carry out investigations

Carry out improvement projects

How You'll Work.

Team & Collaboration

Support operations group; Support Manufacturing Engineering Group; Work with manager; Travel to suppliers

Communication Scope

Communication Skills; Conveys information effectively; Actively listens; Resolves conflict constructively

Process & Methodology

Project management, Project phases, Cost justification, Project management, Installation, Training, Qualification, Implementation, Planning Skills

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