安规网
标题: System Verification Engineer-IEC [打印本页]
作者: vicky.shi 时间: 2013-9-12 10:11
标题: System Verification Engineer-IEC
本帖最后由 vicky.shi 于 2013-9-12 13:56 编辑
SUMMARY OF POSITION:
As independent contributor, documenting the system level of the testing plan, testing protocol and testing summary report for medical equipment.
ESSENTIAL FUNCTIONS:
- Work closely with develop engineer to fabricate/evaluate the electrical/mechanical prototypes.
- Provide fair and accurate test data and expertise to optimize product design and reduce the quality risk.
- Issue tracking/resolving in HW/SW/ME test and reports generating, document control.
- Contribute the product design quality by diligent/innovative thinking in testing/issue resolving.
- Implement the quality plan to ensure the quality of the products by the effective and harmonious communication.
- To perform analysis and teardown to investigate failures and list of potential design issues.
- Coordinate and provide validation test facilities resources per product development requirement
- Attend the team meetings by preparing the test agenda, project test updates.
REQUIREMENTS:
- Education: Bachelor or above all, technical educational background is a must.
Experience:
- More than 4 years of related working experience in IEC 60101 related safety test is must.
- 3 years of experience in conducting the functional test (regression test) / Non-functional test, integration test, system test and unit test
- 3 years of related working experience in biocompatibility, sterilization assurance and mechanical test is prefer
Required technical skills / Qualifications:
- Strong capability to know IEC60601-1 1998A1& A2 , IEC60601-1 .IEC60601-1-8 IEC60601-2 series
- Knowledge in at least one of following domain: VT product IEC test needs, EbD product IEC test needs, NGP product test needs.
- Be familiar with test sequence in standard and risk management
- Familiar with general test equipment in mechanical/electrical Lab.
- Effectively communicate and collaborate with other team member.
- Clear thinking, smart. Enjoy resolve technical issue.
- Strong sense of accountability.
- Quick learner, good at mathematics.
Preferred:
- Working experience in certification lab is a plus.
- Familiar with statistical analysis tools is a plus.
- Good communication skills both oral and written in English is a plus.
- Bachelor degree of well-known college is preferred.
- Familiar with regulatory standard in medical instruments is a plus
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
- Work closely with various technical engineers such like SW/ME/EE; frequent contacts with internal/external labs.
WORKING CONDITIONS:
- Combination of laboratory and office environment.
- Based in Shanghai, China.
欢迎光临 安规网 (http://bbs2.angui.org/) |
Powered by Discuz! X3.2 |