Hardware Verification Engineer

Fresenius Medical Care · Suzhou

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Job Responsibilities
1) 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 cases 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 hi h level desi n reviews

2) 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 samples preparing, operation debugging & simulating according to the project needs

Qualifications, experience, know-how and skills critical for success*
1) Required training and education:
• BS or MS in Mechanical Engineering 'automation Engineering or related filed
2) Required professional experience (in years):
• Sr. Verification Engineer--Minimum 5 ears in Medical R&D related area (Prefer HD area)
3) Important personal qualities:

• Ownership & Responsibility
• Hard working, focusing on Quality & Details.
• Team la er, good communicator

4) Other specialized knowledge:
a) Technical knowledge

• Familiar with QMS related standard (ISO 9001, ISO 13485 etc.)
• Familiar with Medical Device safety standard (IEC60601-1, GBfT9706.1, GBfT14710, etc.)
• Familiar with mechanical design software, like auto CAD, Creo, Solidworks, UG..
• Experience in mechanical design and manufacture process is preferred.
• Experience in material test such as MSDF, UL94 test, UV Test.

b) Languages
• Strong English verbal and written communication skills.
c) IT skills
• Have excellent skills with general computer use and office applications such as Microsoft Word, Excel, and Power point.
d) Product knowledge
• Familiar with medical device industry and knowledge of HD dialysis machine is preferred.
5) Special personal requirements:

• Willingness to travel if business required and
• Be comfortable working in a global organization
• Be comfortable working under pressure

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