Description:
• Research, design, develop and test in connection with the manufacturing of medical device products.
• Develop and implement solutions based on Lean Production system design and transformation principles, tools and techniques including Six Sigma.
• Implement the operation cost improvement projects and oversees process improvement activities.
• Operate various computer-assisted engineering design tools and equipment to perform engineering tasks.
• Confer with engineers, customers, or others to discuss existing or potential engineering projects or products.
• Coordinate support documentation and testing activities to ensure compliance with specifications and customer requirements.
• Prepare specifications for purchases of materials or equipment.
• Perform detailed calculations to compute and establish manufacturing specifications.
• Develop assembly methods and oversee prototype builds
• Lead test method development and have strong knowledge of measurement system analysis (e.g. Gage R&R)
• Analyze test data, interpret results and formulate conclusions
• Oversee project production efforts to assure projects are completed on time.
• Coordinate activities with vendors/suppliers.
• Work closely with the site project engineers to implement improvement projects in the sites.
Technical/Soft skills:
• Bachelor in Engineering and Science
• progressive experience
• Plastics and metals processing
• Mechanical Process Validation (IQ, OQ, PQ, TMV, G R&R, Equipment Software Validation)
• FDA (21 CFR, Part 820)
• Statistical Analysis Tools such as Minitab
• CAD modeling (Preferred Solidworks)
• GD&T (ASME Y14.5)
• Process improvement principles such as Lean, Six Sigma
• Ability to take an idea to the production (including feasibility study, modeling, prototyping, testing, …)
• Written and communication skills
• Multiple project planning and execution
• Work in a cross functional, cross cultural environment
• Work in a suppliers
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Last updated on Jan 12, 2017