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
• Consultantin regard of internal and external standards requirements
• 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
• 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:
• Familiarwith QMS related standard (ISO 9001, ISO 13485 etc.)
• StrongEnglish verbal and written communication skills.
c) IT skills
• Haveexcellent skills with general computer use and office applications such asMicrosoft Word, Excel, and Powerpoint.
• 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
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