In this role, you have the opportunity to
Conduct FDA and other regulation compliance activities for engineering relative, eg: Risk management in engineering relative, flow design, process validation and verification, FMEA, Control plan and other FDA relative activities.You are responsible for
Conduct NPI transition technical activities from design to manufacturing, be technical contact window with R&D center and local team (mainly FDA and regulation compliance), coordinates the compliance review in each stages of product transition.
Lead product compliance activities in completely manufacturing process and whole product lifecycle. (All new product development stage and mass production control).
Understand product design concept, meet product technical requirement, and mature process development, to secure the product technical realization and success delivery in each milestone (mainly FDA and regulation compliance). (Process flow, DFA/DFM, FMEA, control plan, risk management, working instruction, releasing reports, testing reports, trail run reports etc.) .
Participate the project review to ensure industrialization realization in quality compliance.
Be responsible for non-compliance investigation, analysis, and relative actions driving.
You are a part of
A professional site engineering team who has frequent connection with global R&D and Site Operations team.
To succeed in this role, you should have the following skills and experience
Education: Bachelor degree or above, major in Science or Engineering, Electro-mechanical, or other appropriate technical discipline is preferred
Experience: More than 8 years engineering experience Relative working experience in product design, mechanical design, manufacturing process development or assembly experience, NPI relative field is required, experience in medical device background is preferred,.
Competency and Skills: Good Communication and Good English skills are required. Experienced at CAD software such as UG, Solidworks ,etc. is a plus
In return, we offer you
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. 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 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.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .