Technical leader, Hardware Verification

Fresenius Medical Care

🇨🇳 China
Hybrid
1 day ago

Test Automation
EMC
MATLAB
LabVIEW
Microsoft Word
Excel

1 day ago

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Job Responsibilities1) Main tasks:Tasks performed regularly which form the essential characteristics of the position.• Organization and execution of product verification of medical products, accessories and modules.• Review product requirements together with electronic designers to ensure their testability• Planning and organization of the system verification incl. Coordination with other departments, projects and external labs• Design electronic test cases according to product and component requirements, definition and creation of test set-ups• Execute tests according to test cases, creation of associated verification documents an ensure such documentation is audit proof• Routine instrument maintenance in test lab• Ensure certain amount of test automation• Be a professional at test method design, samples preparing, operating, debugging & simulating according to the project needs2) Secondary tasks:Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position.• Technical support to the Team, Method, test setup and Lab Running3) Miscellaneous tasks:Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work.• Other tasks assigned by superior leaderQualifications, experience, know-how and skills critical for success*1) Required training and education:Full-time BS or MS degree, major in electronic information, automation, communication engineering, etc.2) Required professional experience (in years):• Minimum 8 years in Medical R&D related area (Prefer HD area)• Be familiar with basic knowledge of digital and analog circuits• Proficient in using basic electronic test instruments (such as multimeter, oscilloscope, signal source, spectrum meter, etc.) • Familiar with basic EMC knowledge, preferably with relevant test experience• Familiar with basic medical safety testing, preferably with IEC60601-1 related testing experience• Can write electronic related test cases independently, including but not limited to instrument selection, sample quantity, test method, etc.3) Important personal qualities:• Ownership & Responsibility• Hard working, focusing on Quality & Details. • Team players, good communicator4) Other specialized knowledge:a) Technical knowledge• Familiar with QMS related standard (ISO 9001, ISO 13485 etc.)• Understanding of the international standards and Chinese standards for medical devices is desired.• Experience of EMC test and EMC test equipment operation is desired, knowledge of wireless test is plus.• Experience working with communication protocols (e.g., RS232, CAN] LAN, etc.) is plus. • Good knowledge of tests specification with Matlab/Simulink or Labview is a big plus.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 preferred5) Special personal requirements:• Willingness to travel if business required and• Be comfortable working in a global organization• Be comfortable working under pressure

Technical leader, Hardware Verification · Fresenius Medical Care

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