Responsibilities:
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.
为保障每一位候选人的平等就业权利，费森尤斯医疗中国作为“杰出雇主”，承诺在招聘和雇佣过程中积极采取行动践行“DE&I（多元、平等、包容）”理念，以确保***、少数族裔、退伍军人、残疾人和不同性取向和性别身份的个体等都能够获得平等就业机会。