Posted on Oct 12th 2019

Advanced Safety & Regulatory Engineer

中国,辽宁,沈阳

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,辽宁,沈阳

Full time

403657

保存职位

Job Title

Advanced Safety & Regulatory Engineer

Job Description

In this role, you have the opportunity to

·         Lead Safety and Regulatory activities for CT products in the medical imaging business that will help improve the lives of millions of millions of people around the world, while advancing Philips digital transformation journey as a global leader in Health Technology.

The Safety & Regulatory Engineer will play a very important role in ensuring CT products designed by Philips are of the highest quality and comply with national and international standards and regulation requirements.

You are responsible for

  • Plan, schedule, manage, conduct and support safety and regulatory tasks (e.g., type testing including EMC, Safety, performance..., submission documents for NMPA, CE and FDA) with projects assigned
  • Design for safety and compliance to meet the standards and regulation
  • Conduct product reviews and inspections according to standards requirements
  • Prepare formal product type testing reports for submission with Third-party agencies including NMPA, CB and NRTL
  • Work with different agencies including NMPA, NB and FDA to obtain product certifications
  • Leading marketing clearance and product registrations activities internal in R&D (NMPA, FDA, EU)
  • Support audits conducted by NMPA, CE, MADSAP, Russia, Korean and Brazil etc
  • Product Safety & Regulatory roadmap

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 Systems Engineering Group Leader, with Cross-Functional and Product Managers as your key stakeholders.

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

Minimum Qualifications:

  • Master's degree or equivalent in Engineering and/or business discipline or alike experience.
  • Minimum 5+ year of relevant experience in medical product engineering or in a similar field.

Desired Qualifications:

  • Master’s degree in Electronics, Electrical, Physics or Biomedical Engineering and 3+ years engineering experience
  • Proficiency with medical device safety and compliance, e.g., design for safety , test methods
  • Proven excellence in the process of medical device marketing clearance and product registrations (NMPA, FDA, EU)
  • Deep insight in ‘’Design for EMC’’ for the complicated medical device
  • Knowledge and experience spanning multiple engineering disciplines (e.g. electrical, electronics, physics and systems engineering) is advantageous.
  • Medical diagnostic industry awareness
  • Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international. This includes but is not limited to organizations such as FDA, IEC, ISO, NMPA, ACR, AAPM, COCIR, MITA and other directives such as RoHS and WEEE. Examples include: FDA 21CFR820.30, IEC 60601-1, IEC 60601-1-2, IEC60601-1-3, IEC 60601-2-44, IEC 62304, IEC62366-1 and ISO 14971.
  • Knowledge and experience spanning multiple engineering disciplines (e.g. electrical, electronics, physics and system engineering) is advantageous.
  • Experience of Project and process management

Skills:

  • Good communication and influence skills.
  • Strong written, verbal, and interpersonal skills while communicating in both English and Chinese.
  • Demonstrated leadership and experience to work with cross-functional teams to drive the output
  • Influencing skills; Team player; Networking skills; Negotiation skills.

In return, we offer you

A path towards your most rewarding career. Philips is growing its technical capability enterprise wide. Succeeding in this systems engineering-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise.

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 3 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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