SSMR AT 系统工程师/ System Engineer
Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this greater cause. It reflects their pioneering spirit, combined with our long history of engineering in the ever evolving healthcare industry.
We offer you a flexible and dynamic environment where you have the space to stretch beyond your comfort zone in order to grow personally and professionally. Sound interesting?
Then come in and join SSMR as 系统工程师/ System Engineer to inspire the future of healthcare.
Your mission and responsibilities:
1. Responsible for fulfilment of all relevant medical standards for our products at AT Shenzhen
2. Create System Functional Specification for Standards and Regulation Requirements.
3. Act as consultant over the complete development process and control the SSMR AT product safety
during development, testing and manufacturing.
4. Plan, Perform or Support for safety and acceptance tests.
5. Support country specific approval process for e.g. CFDA registration testing, FDA 510k reporting, Shared
MDR fulfillment, IEC 60601-1 series standards and etc.
6. Participate in IEC, CFDA standard committee meetings for drafting new standards.
7. Act as consultant for EMC related topics and support EMC testing.
8. Support Notified Body audits, NRTL audit and national audit
9. Support Germany AT Headquarter for Standards & Regulation related topic.
Your qualifications and experiences:
1. Preferred is experience in IEC 60601-1 basic safety and essential requirements and/or corresponding YY Standards.
2. Preferred is experience in IEC 60601-1-2 3rd edition and 4th edition. (EMC)
3. Basic konwledge in requirement engineering.
4. Basic knowledge in medical engineering or clinical use of medical devices, preferably in the range of X-ray, Angiography or Cardiology systems.
5. Fluent in English and good in communication skill.
6. Experience with international employers and customers; capabilities to operate in foreign cultures preferred.
7. International travel is required.
8. B.Sc or M.Sc. degree or comparable education background.
Major in Mechanical or Electrical Engineering, Automation or related disciplines.
Being part of our team:
Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Curious about our culture?
Our culture embraces different perspectives, open debate and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas and celebrate success.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
Job ID: 104382
Organization: Siemens Healthineers
Experience Level: Experienced Professional
Job Type: Full-time