苏州招聘

Responsibilities / Authorities工作职责权限:

1. Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria.

2. Works closely with product development engineering to establish the system design specifications and product requirements.

3. Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles.

4. Performs and documents all engineering studies and reports to satisfy the master verification plan.

5. Plans, coordinates and executes design verification testing to directly support the master verification plan, including any additional activities such as HALT/HASS and IEC 60601-1 testing.

6. Participates with the engineering team to establish and review the design FMEA.

7. Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment.

8. Possesses a comprehensive understanding of HALT/HASS principles, IEC 60601-1 requirements, design FMEA practices, and any industry standards to ensure products satisfy all ISO 13485 requirements.

9. Develop and build the Design Assurance system/process into the current R&D design and development process

Other tasks are authorized by the leaders

Qualifications任职资格:

Education background教育背景: Bachelor Degree in Biomedical Engineering (Master preferred)

Work experience工作经验:
1) 2 years or above working experiences in design verification & validation, composing documents such as protocol, SOP in medical device/pharmaceutical industry is a plus.
2) Familiar with GMP, ISO 9001 / 13485 quality system熟悉GMP，ISO9001/13485质量体系；
3) Good teamwork and communication skill良好的团队合作和沟通技巧。

Competence and skills技能技巧:

1) Teamwork and communication skill团队合作和沟通技巧；
2) Continuous and versatile learning ability全面持久的学习能力；
3) Document management skill文件管理技能；
4) Computer literacy skill熟练使用计算机；
5) Excellent Writing and verbal skill in English英语书面和口语表达能力。

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