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 high level design 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 , operating , debugging & simulating according to the project needs
3) Miscellaneous tasks:
N/A
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 years in Medical R&D related area (Prefer HD area)
3) Important personal qualities:
• Ownership & Responsibility
• Hard working, focusing on Quality & Details.
• Team player, 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, GB/T9706.1 GB/T14710, 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