Technical leader, Hardware Verification

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