Senior Hardware Verification Engineer

Job Responsibilities

1) Main tasks:

• Organization and execution of product verification of medical products, accessories, and modules.

• Ensure that product requirements are testable

• Definition and coordination of test strategies

• Planning and organization of the system verification incl. Coordination with other departments, projects and external labs

• Planning and organization of necessary resources

• Creation of test specifications, test cases and test activities especially in mechanical profession

• Definition and creation of test set-ups, test tool and fixture development as required

• Familiar with various testing equipment (such as micro-meter, pressure-meter, temperature-meter, force-gauge, coordinate measuring machine, material tension test machine etc.) to perform defined testing.

• Execution of system verification to ensure that the design input has been achieved

• Identification, analysis and documentation of deviations

• Creation of associated verification documents acc. to internal and external requirements

• Ensure that such documentation is audit-proof

• Coordination of necessary verification measures in the design change process

• Acting as a “Leader Verification” for development projects (Sr. Verification Engineer)

• Play the role of an independent reviewer for high level design reviews

2) Secondary tasks:

• Consultant in regard of internal and external mechanical standards requirements

• Creation of approval submission documentation.

• Quality assurance for approval submission documentation

• Organize and draft approval submission documentation

• 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 (Sr. Verification Engineer)

• Be a professional at samples preparing , operating , debugging & simulating according to the project needs

3) Miscellaneous tasks:

N/A

Qualifications, experience, know-how and skills critical for success*

1) Required training and education:

• BS or MS in Mechanical Engineering /automation Engineering or related filed

2) Required professional experience (in years):

• Sr. Verification Engineer--Minimum 5 years in Medical R&D related area (Prefer HD area)

3) Important personal qualities:

• Ownership & Responsibility

• Hard working, focusing on Quality & Details.

• Team player, good communicator

4) Other specialized knowledge:

a) Technical knowledge

• Familiar with QMS related standard (ISO 9001, ISO 13485 etc.)

• Familiar with Medical Device Safety standard (IEC60601-1, GB/T9706.1 GB/T14710, etc.)

• Familiar with mechanical design software, like auto CAD, Creo, Solidworks, UG....

• Experience in mechanical design and manufacture process is preferred.

• Experience in material test, such as MSDF, UL94 test, UV Test.

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 is preferred.

5) Special personal requirements:

• Willingness to travel if business required and

• Be comfortable working in a global organization

• Be comfortable working under pressure