Hardware Verification Engineer

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