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.
|