高级验证测试工程师--某500强德资医疗公司亚太研发中心

Tasks*

1) Main tasks:

     Organizationand execution of product verification of medical products, accessories andmodules.

     Ensurethat product requirements are testable

     Definitionand coordination of test strategies

     Planningand organization of the system verification incl. Coordination with otherdepartments, projects and external labs

     Planningand organization of necessary resources

     Creationof test specifications, test cases and test activities

     Definitionand creation of test set-ups

     Familiarwith various testing equipment (such as Multi-meter, pressure-meter, Data- log,Oscilloscope etc.) to perform defined testing.

     Executionof system verification to ensure that the design input has been achieved

     Identification,analysis and documentation of deviations

     Creationof associated verification documents acc. to internal and externalrequirements 

     Ensurethat such documentation is audit-proof

     Coordinationof necessary verification measures in the design change process

     Actingas a "Leader Verification" for development projects (Sr. VerificationEngineer)

     Playthe role of an independent reviewer for high level design reviews

2) Secondarytasks:

     Consultantin regard of internal and external standards requirements

     Verification

     Regulatoryapprovals (Sr. Verification Engineer)

     Riskmanagement (Sr. Verification Engineer)

     Internaland external requirements (such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-16etc.)

     Creationof approval submission documentation.

     Coordinationof regulatory approval activities

     Qualityassurance for approval submission documentation

     Organizeand draft approval submission documentation.

     Strongtechnical support to the Team, Method and Lab Running  

     Bea Coach for R & D internal employees for product(HD etc.) technicalIntroduction & Training(Sr. Verification Engineer)

     Bea professional at samples preparing, operating, debugging & simulatingaccording to the project needs

3) Miscellaneoustasks:

     Othertasks assigned by superior leader

 

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

 

1) Requiredtraining and education:

     BSor MS in EE/ME/BM Engineering or related filed

2) Requiredprofessional experience (in years):

     VerificationEngineer--Minimum 3 years in Medical R&D related area(Prefer HD area)

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

3) Importantpersonal qualities:

     Hardworking, focusing on Quality & Details.

     Teamplayer, good communicator

4) Otherspecialized knowledge:

a) Technicalknowledge

     Familiarwith QMS related standard (ISO 9001, ISO 13485 etc.)

b) Languages

     StrongEnglish verbal and written communication skills.

c) IT skills

     Haveexcellent skills with general computer use and office applications such asMicrosoft Word, Excel, and Powerpoint.

d) Productknowledge

     Familiarwith medical device industry and knowledge of HD dialysis machine preferred

5 ) Specialpersonal requirements:

     Willingnessto travel if business required and conformable to work in a global organization