Technical Leader, Regulatory Verification

Job Responsibilities1) Main tasks:•Support China registration for active medical devices, mainly focus on the type testing related tasks•Be the bridge of national lab and global experts, collect the test methods or reports to fulfill the type test requirement of China NMPA;•Work with China RA and global experts, prepare the dossiers like PTR (Product technical requirement), CER (Clinical evaluation report), innovation reports, etc.•As the technical expert of Global and China standards, participate in China standards and NMPA guidance drafting and discussion, protect the product and market of FMC.•Organization and execution of product verification of medical products, accessories and modules.•Creation of associated verification documents acc. to internal and external requirements, and ensure such documentation is audit-proof•Coordination of necessary verification measures in the design change process•Be a professional at test method design, samples preparing, operating, debugging & simulating according to the project needs, especially for standard related testing •Responsible to medical device EMC test•Responsible to conduct wireless module RF compliance test with 3d party2) Secondary tasks:Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position.3) Miscellaneous tasks:•Internal and external requirements (such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-16 etc.)•Familiar with basic EMC and wireless knowledge, preferably with relevant EMC and RF test experience•Familiar with EMC and wireless related standards (Such as IEC61000, CISPR11, EN300 328, EN301 893 etc.)•Strong technical support to RF and EMC test system building•Creation and approve submission documentation and keep them quality compliance.•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.Qualifications, experience, know-how and skills critical for success*1) Required training and education:BS or MS in EE/ME/BM Engineering or related filed2) Required professional experience (in years):•Minimum 8 years in Medical R&D related area (Prefer HD area) •Minimum 5 years in EMC test area (Prefer medical device) •Minimum 5 ears in RF performance test area (Prefer2.4GHz and 5GHz frequency scope)3) Important personal qualities:•Ownership & Responsibility•Hard working, focusing on Quality & Details. •Team player, good communicator4) Other specialized knowledge:a) Technical knowledge•Familiar with QMS related standard (ISO 9001, ISO 13485 etc.)•Familiar with IEC, GB and YY standards, like IEC60601-1, GB 9706.1 and YY0505, IEC61000, CISPR11, IEC60601-1-2, EN300 328, EN301 893, etc.•Proficient in using basic test instruments (such as multimeter, oscilloscope, signal source, spectrum analyser, network analyser, etc.)•EMC debug experience is a plus•ISO 17025 experience is a plusb) Languages•Strong English verbal and written communication skillsc) 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 preferred5) Special personal requirements:•Willingness to travel if business required and•Be comfortable working in a global organization •Be comfortable working under pressure