• senior design engineer will perform the design and engineering for product development projects from ideation/conceptualization to detail design finalization for manufacturing/assembly. This critical position will be responsible for creating innovative concepts/designs of medical devices to address specific unmet needs of clinical practice and China market. By working with the R&D team and other cross-functional team and following design controls, this position will demonstrate the feasibility of concept, the realizability of detail design, and manufacturability of product in order to successfully launch the products with China-specific competitive and comparative features that enable sustainable business growth in China. This position will also be the point contact to manage business relationship with selected engineering design firm (s) to ensure deliverables as contracted.
• Proactively interact with customers and health care providers. Comprehend and interpret their needs and requirements correctly and transfer the comprehension into novel product concepts/designs effectively.
• Lead and facilitate the innovation process with regard to creating new design ideas/solutions.
• Conceptual design of novel ideas/products to address unmet needs in China market and advance business goals. Development of complex mechanism designs for innovative medical devices and technical problem solving.
• Point person to develop, maintain and manage business relationships with engineering design firms, collaborating with selected partner firms and ensuring their deliverables.
• Define technical solutions for complex problems and lead efforts to realize the technical solutions.
• Front end conceptual design, prototyping and testing of ideas for new products. Use first principles and advanced engineering methods to guide the development process. Use FEA when needed.
• Actively pursue understanding of key technology trends in vascular, oncology, urology or surgical specialty medical products. Evaluate and assess competitive products, processes or new technologies. Advise management of technology trends and risks.
• Lead cross-functional planning, coordination and reviews in all phases of medical device development including concept development, detailed engineering and design for manufacturability.
• Improve and incorporate novel features into existing products to meet the special needs in China market. Confirm product capabilities by designing feasibility and testing methods and systems.
• Perform 3D modeling and tolerance analysis. Generate engineering drawings conforming to ANSI Y14.5M and internal standards.
• Design for Manufacturing/Assembly (DFM). Work closely with injection molding engineers and contract injection molding companies to ensure DFM.
• Design fixtures for assembly, testing and inspection.
• Lead design reviews, DFMEA’s. Develop prototypes for technical & customer evaluations.
• MINIMUMQUALIFICATION
• Mechanical designer or industry designer with a strong mechanical aptitude. BS in Mechanical Engineering a minimum, MS/PhD in Mechanical Engineering strongly preferred.
• Minimum of 6 years’ experience as a designer in engineering design firm or mechanical engineer in medical device industry.
• Be proficiency in utilizing DFSS tools to analyze the design options and evaluate the design and test results
• Proficient in SolidWorks modeling and GD&T, and be good at tolerance analysis.
• Be familiar to FEA and motion animation of mechanism using SolidWorks, or equivalence
• Be experienced on complicated and compact mechanism and trouble-shooting
• Know about how to collaborate with suppliers or design firms to deliver product concepts, design and documentations within project development
• REQUIREMENTS
• Ability to create novel designs based on customer needs.
• Ability to lead and facilitate the innovation process with regard to creating new design concepts/solutions. Must be a self-starter that can start with a blank sheet of paper and land with multiple promising design concepts.
• Experience with ergonomic design and human factors engineering.
• Strong creative ability and advanced technical judgment.
• Advanced knowledge of engineering first principles.
• Experience in designing vascular, oncology, urology or surgical specialty medical products highly desirable.
• Working knowledge of injection molding and medical device assembly processes such as catheter tipping, UV bonding, coating, lubrication will be useful.
• Experience in using FEA to facilitate design optimization and product development process.
• Strong project management, prioritizing and multi-tasking skills to work within tight deadlines.
• Strong analytical and problem solving skills, as well as a good background in product development process.
• Logical approach to the solution of problems and to the product development process with the capacity for original thinking.
• Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
• Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes a plus.

Excellent oral and written communication skills. Clear/Concise documentation and correspondence during project execution.

上班地址：上海