Job Title

Job Description

In this role, you have the opportunity to

The Senior Safety Regulation Engineer is to own product safety design and regulation compliance.

The Senior Safety Regulation 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.

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

• All applicants are required to have the following:
• Have an 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.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this DXR system 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 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.

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.