Job Summary

A Manufacturing Engineer who is bilingual (English/Mandarin) and able to travel 10% of the time abroad during manufacturing transfer. Responsible for process engineering and production support of a product or product line during the life cycle of manufacturing: manufacturing transfer, validation, production technical support and continuous improvement.

Supports technical transfer and manufacturing by providing engineering design, procedures and implementation of assembly methods, test methods, equipment operation, including specification and optimization. Coordinates with global/local team to solve technical issues, Non-Conformities and Complaints. Provides technical support for continuous improvement team efforts focused on process improvement and optimization.

Responsibilities:

Manufacturing transfer

• Writes process procedures, Work Instructions, change orders, equipment specifications, validation plans, and reports.

• Maintain item master, BOM and routing updates in SAP through change orders.

• Responsible for establishing the Manufacturing Quality Plan (MQP) for a product or product line including VSM, process flow, production floor layout, equipment, line balancing, etc.

• Support prototyping and IQ/OQ/PQ process /software validation.

Production Technical support

• Coordinates manufacturing changes, documents through change management and ensures that product equivalence is maintained among different manufacturing sites.

• Coordinates with global/local team to solve technical issues, Non-Conformities and Complaints. Leads resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions

• Lead material localization projects to meet cost target. Coordinates supply chain, quality team and global team to localize and qualify the materials.

Product Champion

• May be required to act as Product Champion for a specific product or product line being the focal point in operations for the products which they have responsibility for.

Continuous improvement

• Provides technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective action proposals utilizing problem solving techniques.

• Performs research on technology, equipment and tooling to improve process quality, yield or cost. Generates proposals for purchase and implementation, including cost of ownership, ROI and benefit analysis

• May participate in Lean Six Sigma projects of significant scope and complexity.

Requirements:

• B.S. in Engineering on instrument or mechanics or electronics

• A minimum of 5 years of experience related to the areas given above or suitable equivalent combination of education and experience.

• Medical device production experience is plus

• Process Improvement background and/or manufacturing transfer project experience is desirable.

• Prior experience with Lean/Six Sigma preferred.

• SAP experience is plus

• Technical mindset and skills

o Instrument assembly and test prcess

o Fixtures development for test and assembly

o Process validation and verfication

• Properly interpret mechanical drawings and electrical schematics

• Understand medical device quality system

• Touble shotting / Analytical skills

• Process improvement/Lean knowledge

• Strong verbal, written in English

• GDP (Good document practice) mindset

• Strong motivational, interpersonal and leadership skills

• Customer focus

其他信息
语言要求：英语
行业要求：全部行业