Main Tasks:

• Organization and execution of product verification of medical products, accessories, and modules.
• Ensure that product requirements are testable
• Definition and coordination of test strategies
• Planning and organization of the system verification incl. Coordination with other departments, projects and external labs
• Planning and organization of necessary resources
• Creation of test specifications, test protocols and test activities especially in mechanical profession
• Definition and creation of test set-ups, test tool and fixture development as required
• Familiar with various testing equipment (such as micro-meter, pressure-meter, temperature-meter, force-gauge, coordinate measuring machine, material tension test machine etc.) to perform defined testing.
• Execution of system verification to ensure that the design input has been achieved
• Identification, analysis and documentation of deviations
• Creation of associated verification documents acc. to internal and external requirements
• Ensure that such documentation is audit-proof
• Coordination of necessary verification measures in the design change process
• Acting as a "Leader Verification" for development projects (Sr. Verification Engineer)
• Play the role of an independent reviewer for high level design reviews

Secondary Tasks:

• Consultant in regard of internal and external mechanical standards requirements
• Creation of approval submission documentation.
• Quality assurance for approval submission documentation
• Organize and draft approval submission documentation.
• Strong technical support to the Team, Method and Lab Running
• Be a Coach for R&D internal employees for product (HD etc.) technical Introduction & Training (Sr. Verification Engineer)
• Be a professional at sampling, operating, debugging & simulating according to the project needs

Qualifications:

• BS or MS in Mechanical Engineering/automation Engineering or related filed
• Ownership & Responsibility
• Hard working, focusing on Quality & Details.
• Proactive to take challenges
• Team player, good communicator
• Familiar with QMS related standard (ISO 9001, ISO 13485 etc.)
• Familiar with Medical Device Safety standard (IEC60601-1, GB/T9706.1, GB/T14710, etc.)
• Familiar with mechanical design software, like auto CAD, Creo, Solidworks, UG….
• Experience in statistical data analysis, Gage R&R analysis, test method validation
• Experience in mechanical design and manufacture process.
• Experience in material test, such as MSDF, UL94 test, UV test, chemical resistance test.
• Experience in measuring with Combined Measuring Machine or similar dimension measuring equipment.
• Experience in component lifetime or reliability test
• Strong English verbal and written communication skills.
• Have excellent skills with general computer use and office applications such as Microsoft Word, Excel, and Power point.
• Experience in using Minitab for statistical data analysis
• Familiar with medical device industry and knowledge of HD dialysis machine is preferred

To ensure the equal employment rights of every candidate, Fresenius Medical Care China, as a "Top Employer," is committed to actively taking actions to implement the DE&I (Diversity, Equality, Inclusion) and company purpose. This aim to ensures that Minorities/Females/Veterans/Disability/Sexual Orientation/Gender ldentity have equal employment opportunities.