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**Job Function: **
R&D Product Development
**Job Sub Function: **
Biomedical Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Shanghai, China
Job Description:
**KEY RESPONSIBILITIES/TASKS/ 主要职责/**任务
- Provide leadership in design & device implementation to support entire product life cycle of various products with focus on Quality Engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control.
- Apply tools and methods (for example: Six Sigma, Lean) to realize new product or process introductions as well as process and business improvements.
- Provide leadership and technical expertise to ensure conformance to ISO, FDA & MDR based quality systems.
- Review and approve the release of new products and design changes ensuring quality requirements are met.
- Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
- Act as technical liaison between product development, manufacturing, external manufacturers & suppliers.
- Use analytical problem-solving skills for root cause investigations.
- Use sound statistical applications in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Coaching, Data Savvy, Detail-Oriented, Feasibility Studies, Inventory Management, Preclinical Research, Project Schedule, Prototyping, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy