Posted on Oct 12th 2019

Advanced Risk Management and Usability Specialist

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

417957

保存职位

Job Title

Advanced Risk Management and Usability Specialist

Job Description

In this role, you have the opportunity to

Develop and maintain Risk Management Files according to ISO14971, which includes risk management plan, risk management matrix, risk management report and risk assessment.

Responsible for medical device usability engineering activities, including planning and executing formative & summative testing according to IEC62366 & FDA Guidance. And completed related deliverables.

You are responsible for

  • Owns Risk Management (ISO 14971) activities. Leading cross-functional teams in planning, analyses (DFMEA, Risk/Benefit) and mitigations.
  • Maintains risk management file for the whole lifecycle of DXR products.
  • Coordinate approbation activities and supports risk management initiatives.
  • Coordinate with cross function team to plan and execute usability formative and summative testing.
  • Deliver and maintain usability documentation for demonstrating medical device regulatory compliance. Such as IEC62366, FDA Guidance.
  • Works with Product Development Manufacturing Engineering in the development of test fixtures, develop production acceptance criteria and test methodology.
  • Coordinates with R&D in the review of technical 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

All applicants are required to have the following:

  • Practical knowledge of ISO 14971 and related standards.
  • Practical knowledge of IEC 62366, FDA and others related usability standards.
  • Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Regulation.
  • Familiar with ISO, IEC standard, Medical Device Directive, and other international medical device requirements and standards.
  • Familiar with risk management techniques. (i.e. Risk Analysis, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), etc.)
  • Preferred experience with FDA and European regulated medical devices.
  • 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.
  • 3-5 years of experience in medical device system.
  • Strong collaboration, negotiation, and conflict resolution skills

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this DXR risk management Engineer role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

Our benefits are very competitive and designed around your preferences:

• We offer a market conform salary

• A variable bonus based on both Philips results and personal performance

• Convenient working conditions in office

• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

• Attractive collective health insurance package

• Opportunity to buy Philips products with discount

• Healthy work-life balance

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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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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