We at Siemens Healthineers? are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge
medical technologies and services, we don’t stop there. We’re also deeply invested in our 46.000 people with thehearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.
If you are ambitious and change makes you thrive, help transform Siemens Healthineers into a learning organization.
職責描述：
What are the responsibilities?
?Work in a global R&D regulatory team with both international and local engineers to develop CT (Computed Tomography) system for the global market
?Development of CT System EMC related topics and handle CT EMC testing.
This including: IEC 60601-1-2 EMC testing and YY0505 EMC testing. Fix EMC problem during testing.
?Risk assessment for CT system with EMC disturbance test items.
?Deal with R&TTE related topic which EMC was related.
?Planning, coordination, implementation and control of the relevant work packages for the regulatory related, CFDA registration testing, FDA 510k reporting, MDR fulfillment, Audit support, IEC 60601-1 series standards and etc.
?Working for IEC, CFDA standard committee for writing and drafting new standards.
?Functional safety checking for CT system.
?CT Standard & law management.
?Support Germany/USA plant for regulatory related topic.
This position may suit you best, if building learning organizations is your expertise and you have extensive experience with Top Management Learning and Leadership Development.
What do I need to qualify for this job?
任職要求：
Capability:
?Strong sense of responsibility, integrity, proactive, quick learning ability and good team work.
?Strong communication skill on technical topics.
?Strong self-learning ability for new field.
?Willing to travel.
Education:
?M.S. degree or comparable education in Computer Science, Mechanics/ electronics, automatics or related disciplines
Knowledge / Experience
?At least 4 years experiences in medical equipment EMC testing or certification field.
Know well about IEC 60601-1-2, 3rd edition and 4th edition.
?Experience of CT EMC testing/certification was preferred.
?Known R&TTE/Wireless related EMC topic.
?Known the philosophy of IEC 60601-1, basic safety and essential requirement.
?Known how to do risk assessment for medical system.
?3rd party/test house experience was preferred.
?International orientation experience with international employers and customers capabilities to operate in foreign cultures preferred
?Proficiency in verbal and written English communications (CET-6 preferred)