Posted on Oct 12th 2019

Advanced Safety Regulation Engineer

中国,江苏,苏州

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,江苏,苏州

Full time

409759

保存职位

Job Title

Advanced Safety Regulation Engineer

Job Description

In this role, you have the opportunity to

The Approbation Engineer is to provide technical support help Regulatory Affairs Engineer finish product regulatory registration with in-depth knowledge of products and standards.

You are responsible for

  • Break down safety and regulatory requirement such as IEC/UL/CE/FDA/NMPA as well as other regulators in worldwide into the design specification requirement.
  • Cooperate with external NRTL lab such as TUV to finish system type test and get TRFs.
  • Be responsible of the system regulatory technical document, such as PTR, GSPR.
  • System ECO design, such as EUROHS, REACH and China ROHS.
  • System label design.

You are a part of

A progressive and energetic team that contributes directly to the growth of the business. You have a direct reporting line to the Manager of DXR system engineering with Cross-functional team as your key stakeholders.

To succeed in this role, you should have the following skills and experience

In return, we offer you

All applicants are required to have the following:

  • Have advanced understanding about IEC60601 series including EMC or equivalent standards.
  • Have advanced hardware knowledge either in electronics and control system or in mechanical system.
  • Be able to specify clear technical requirements according to the IEC standard input.
  • Must have excellent both Mandarin and English communication & negotiation skills (spoken, written and presentation).

Although not essential, it would be desirable if applicants have the following:

  • Bachelor’s Degree in Engineering or related field required. Master’s Degree preferred.
  • 1-3 years of experience in medical device hardware design and approbation work.
  • Good teamwork spirit and soft skill; be able to drive and solve problem in efficient way.
  • Familiar with ISO14971, ISO 13485, ISO17025 standard.
  • Understand the matured industry product development process
  • Background of Medical devices (DXR) is preferred.

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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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