常熟招聘

Qualification 岗位要求

1. Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaption 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.

10. Other tasks and authorized by the supervisor.

Education background教育背景:

Bachelor degree in Biomedical Engineering (Master preferred)

Work experience工作经验:

1) 10 years or above working experiences in design verification & validation, composing documents such as protocol, SOP and/or IQOQPQ in medical device/pharmaceutical industry is a plus.

2) Familiar with GMP, ISO 9001/13485 quality system.

3) Good teamwork and communication skill.

费森尤斯集团（德国）是一家全球性的医疗保健服务公司,以优质的医疗产品和可信赖的治疗服务享誉全球，是世界五百强企业之一。费森尤斯集团由位于全球范围内的四个独立的事业部组成，包括费森尤斯医疗用品、费森尤斯卡比、费森尤斯赫里奥斯、费森尤斯奥美德。
江苏费森尤斯医药用品有限公司（以下简称“费森尤斯常熟工厂”）隶属于费森尤斯医疗用品，公司成立于2007年7月，是一家集研发和生产功能于一体的企业。公司主要生产用于血液透析的配套产品。现我公司诚邀勤奋敬业、不断超越自我的专业人才加入费森尤斯大家庭！
费森尤斯常熟工厂能为在职员工提供良好的培训与无限的发展空间，同时您也可以在日常工作中领略到多国文化和谐交融的氛围，提高自己的口语水平并拓宽国际视野。另外，公司还为员工提供免费工作餐及常熟市内／苏州班车、年底绩效奖金、带薪年假及其他欧美独资企业所能享有的待遇