职位描述
Verification Engineer is responsible for all product verification related activities of Dr ger products. This includes:
1. Organisation and execution of product verification of medical products, accessories and modules;
2. Preparation of records for regulatory approvals;
3. Execution of product risk management;
4. Guidance concerning internal and external standards requirements.
岗位职责
Organisation and execution of product verification of medical products, accessories and modules
- Creation of test specifications and test reports
- Definition, creation and validation of test set-ups
- Definition and creation of test equipment
- Calculation of measurement uncertainties/inaccuracies
- Execution of system verification: Verify that the product fulfils 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 CFDA type testing:
main contact for CFDA approval of locally developed and imported medical devices
responsible for the technical part of CFDA 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
任职要求
Bachelor degrees and above in Engineering
2-5 years of practice/working experience in R&D Center of Manufactures
Professional Competencies:
- Knowledge of medical device related standards – advanced level
- Knowledge of IT tools like MS Office – advanced level
- Knowledge of project management – basic level
- English in both written and oral – advanced level
Behavioral Competencies:
- Learn and develop – advanced level
- Cooperate and communicate – advanced level
- Intercultural awareness – basic level
- Pay attention to detail – advanced level
- Solve problems – advanced level
