Philips Safety and Compliance Engineer in Suzhou, China

In this role, you have the opportunity to

Lead Safety and Compliance 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 & Compliance 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 requirements.

You are responsible for

  • Plan, schedule, manage, conduct and support safety and compliance tasks (e.g., EMC, Safety...) with projects assigned

  • Design for safety and compliance to meet the standards and regulation

  • Conduct safety testing and review test results

  • Conduct product reviews and inspections according to standards requirements

  • Prepare formal product safety compliance document for submittal to Third-party agencies

  • Work with Third-party agencies to obtain product certifications

  • Support marketing clearance and product registrations (CFDA, FDA, EU)

  • Support audits conducted by Third-party agencies

  • Product Safety & Compliance 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 Sr. Manager, with Cross-Functional and Project Managers as your key stakeholders.

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

Minimum Qualifications:

  • Bachelor's degree or equivalent in Engineering and/or business discipline or alike experience.

  • Minimum 3 + 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 (CFDA, 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, CFDA, ACR, AAPM, COCIR, MITA and other directives such as RoHS and WEEE. Examples include: FDA 21CFR820.30, IEC 60601-1, IEC 60601-2-44, IEC 62304 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

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

In this role, you have the opportunity to

Lead Safety and Compliance 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 & Compliance 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 requirements.

You are responsible for

  • Plan, schedule, manage, conduct and support safety and compliance tasks (e.g., EMC, Safety...) with projects assigned

  • Design for safety and compliance to meet the standards and regulation

  • Conduct safety testing and review test results

  • Conduct product reviews and inspections according to standards requirements

  • Prepare formal product safety compliance document for submittal to Third-party agencies

  • Work with Third-party agencies to obtain product certifications

  • Support marketing clearance and product registrations (CFDA, FDA, EU)

  • Support audits conducted by Third-party agencies

  • Product Safety & Compliance 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 Sr. Manager, with Cross-Functional and Project Managers as your key stakeholders.

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

Minimum Qualifications:

  • Bachelor's degree or equivalent in Engineering and/or business discipline or alike experience.

  • Minimum 3 + 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 (CFDA, 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, CFDA, ACR, AAPM, COCIR, MITA and other directives such as RoHS and WEEE. Examples include: FDA 21CFR820.30, IEC 60601-1, IEC 60601-2-44, IEC 62304 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

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .