Principle System Engineer
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Posted on:
Yesterday
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1 Vacancy
Job Summary
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years our team has driven meaningful innovations in kidney care. As we build on our legacy we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams and longer fuller lives for patients that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space it will also offer meaningful work to those who join us. At Vantive you will become part of a community of people who are focused courageous and dont settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
- Essential Duties and Responsibilities.
- Lead design of local Peritoneal Dialysis devices as well as integrated solutions (combination with disposables PD solutions Apps and other devices or SW from internal or 3rd party) for China market according to defined strategy or projects. Including but not limited to: customer needs collection and analysis functional requirement development concept and high-level design feasibility study design transfer trouble shooting etc.
- Support NMPA approval of local and global Peritoneal Dialysis devices including but not limited to support/execute type testing prepare R&D related dossier answer technical questions support CER and clinical trial etc.
- Cooperate with cross functional team and global R&D to sustain current Peritoneal Dialysis devices on China market. Support to investigate and solve site issues.
- Responsible for compliance of Peritoneal Dialysis related regulations and standards. Provide technical comments to shape policies.
- Serve as main contactor between China function teams and global R&D to enhance collaboration and support to China business.
- Support global R&D to understand China requirements. Collect translate and clarify China specific requirements as input to product core team.
- Provide technical support to China factories Commercial Service RA and other function teams. Support business development in China
- Qualifications.
- Self-motivated with good communication skills. Strong written verbal and interpersonal skills while communicating in both English and Chinese.
- Capable of analyzing and solving complex problems individually or cooperating with team.
- Experienced in development and lifecycle management of electromechanical medical devices with strong technical background.
- Deep domain knowledge of medical devices in systems engineering and at least one of the following disciplines: electrical HW design Usability Reliability SW lifecycle management or Hydrodynamics.
- Understanding and adherence to NMPA FDA and EU MDR design control principles requirements regulations standards and good practice.
- Comfortable working in a cross-culture environment teamwork spirit and open minded
- Education and/or Experience.
- Bachelor with at least 8 years experience Master or Ph. D. with at least 5 years of experience in medical devices or relevant industries.
- Major in Electrical Computer Science Software engineering Biomedical engineering Physics or other relevant education background.
- Experience should include at least 3 years of relevant technical management/coordination experience e.g. Technical Project Leader Lead System Designer System Engineer Lead System Integration etc.
- Pro experience to coordinate global R&D and/or local MK is preferred.
- Prio experience in Dialysis is a plus.
Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information. Form Link
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Key Skills
- Enterprise Software
- SAP Warehouse Management
- AWS
- Solution Architecture
- SAP EWM
- SAP Finance & Controlling
- SAP Supply Chain Management
- SAP S/4HANA
- Enterprise Sales
- Pre-sales
- Management Consulting
- Oracle
About Company
The user-friendly Amia APD system, powered by Sharesource Connectivity Platform, is designed to simplify home peritoneal dialysis for both clinicians and patients.
