Manufacturing Engineer

San Jose  ‐ Onsite
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Keywords

Description

SUMMARY:
The Manufacturing Engineer will be a core team member on multiple parallel projects or product transfers responsible for providing engineering support to manufacturing, execution of project tasks and the development of existing and new process technologies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Core team member for multiple parallel projects or product transfers responsible to deliver on time and in budget to the required quality, plus deliver other pre agreed measures of success. Products range from those exiting design phase to recurring manufacturing products.
  • Responsible to support all phases of the project/product transfer from scoping/planning through all transfer or NPI activities and continue to support the product until in a stable manufacturing environment in the receiving site.
  • Actively contributes to the project activities through completion of tasks as a core team member including customer, supplier and internal interaction.
  • During project duration support manufacturing as the manufacturing engineer providing line support for quality and technical issues to ensure customer supply is not impacted.
  • Manage a variable workload to meet/exceed key Performance Indicators (KPIs), such as yield, on time delivery, throughput, process capability, OEE and productivity.
  • Provides technical leadership in the projects assigned and provide Design for Manufacturing input to R&D, customers and product commercialization teams.
  • Drive process and product improvement activities to promote product quality, efficiency and manufacturability using statistical techniques, lean manufacturing tools, Six Sigma, tool/fixture design, design experimentation for process and equipment.
  • Complete process validation for processes and products including IQ, OQ, PQ, & PPQ.
  • With the project team minimize project risk for both the customer and the company.
  • Will require availability for short term assignment to receiving site for any product transfer projects - generally Ireland or Singapore.
  • Financial capabilities. Having appreciation for Cost of Goods Sold e.g. BOM & Labor analysis.
  • Update manufacturing procedures, specifications etc. as required through ECO process.

REQUIREMENTS:
  • Degree in Mechanical or Manufacturing Engineering or related discipline.
  • 5 years+ of experience in medical device industry with proven track record in project execution. Must be able to support multiple projects at the same time.
  • Must be available for assignment to product transfer site for 1-3 months.
  • Product transfer, product validation and catheter assembly experience a definite advantage including braided shaft assembly and bonding processes.
  • Must be able to plan, organize, and implement multiple concurrent tasks and projects.
  • Experience in customer communications and working with external stakeholders.
  • Demonstrate a practical understanding of lean manufacturing principles and statistics.
  • Excellent verbal and written communication skills.
  • Must demonstrate the ability to set and meet deadlines.
  • Knowledge of ISO & FDA compliance.


To find out more about Real please visit www.realstaffing.com
Start date
02/2014
From
Real Staffing
Published at
20.02.2014
Project ID:
667926
Contract type
Freelance
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