Technical leader, Hardware Verification at Fresenius… · Suzhou

Technical leader, Hardware Verification

Location: Suzhou, Jiangsu, China · Hybrid

Job Responsibilities 1) 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 needs 2) 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 Running 3) 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 leader Qualifications, 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 communicator 4) 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 preferred 5) Special personal requirements: • Willingness to travel if business required and • Be comfortable working in a global organization • Be comfortable working under pressure