Technical leader, Hardware Verification
Fresenius Medical Care · Suzhou
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