Philips Advanced System Engineer in Shenyang, China
In this role, you have the opportunity to
- incremental request for CT project, will response for MMIS feature, to lead and integrate all design activities in project.
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
Support CNAS lab built-up and testing execution
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
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
In return, we offer you
A path towards your most rewarding career. Succeeding in this 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.
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.