深圳招聘

Software Test Engineer（欧美独资医疗设备公司，3年以上软件测试经验，英语熟练）

Main objective/s:
？ Organisation and execution of product verification of medical products, accessories and moduls.
？ Preparation of records for regulatory approvals
？ Execution of product risk management
？ Guidance concerning internal and external standards requirements
？ Additional assigned roles and scope
？ Process owner / author for verification related internal processes and standards
？ Laboratory and test equipment delegate
Responsibilities and Accountabilities:
Define test strategy/test plans/ schedules for verification and validation testing on assigned projects.
Define, create V&V documentation as necessary to support product release and 510K submittal requirements.
Conduct SW and HW testing and identify any defects.
Track identified product defects and ensure that corrective actions are taken.
Review project release documentation from assigned group.
Define and implement SW Test environments and or methodologies to improve product quality and costs.
？ Organization and execution of product verification of medical products, accessories and moduls.
? Creation of test specifications and test reports
? Definition, creation and validation of test set-ups
? Definition and creation of test equipment
? Calculation of measurent uncerrtainties/inaccuricies
? Execution of system verification: Verify that the product fulfills all technical system requirements, external standards and safety requirements.
? Identification, analysis and documentation of deviations found during testing.
? Support engineers during problem solving process
? Creation of associated verification documents acc. to internal and external requirements
? Ensure that such documentation is audit-proof
？ Type testing

? Support of SFDA type testing:
- main contact for SFDA approval of locally developed and imported medical devices
- responsible for the technical part of SFDA approval (in collaboration of Regulatory Approval team)
？ Consultant in regard of internal and external standards requirements
? Consultant for questions regarding:
- Verification
- Regulatory approvals
- Test equipment

？ Pool of potential Key Performance Indicators:
？ On time fullfillment of project milestones/assigned tasks
？ Level of specification fulfillment by the product (Result of verification/validation)
？ Quality of documentation: Amount of audit findings
？ Local adaptation or additional individual, personal tasks:
？ Special tasks assigned by Department Manager
？ R&D laboratory officer, responsible for the R&D and verification lab.
Requirements:
？ BS in Biomedical Engineering, Computer Science or equivalent degree
？ 3+ years in software development and testing environment
？ Good English communication skill

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