·Join R&Dprojects as one of the Cross Functional Team members and be responsible forSystem Engineering related tasks, including but not limited to transferringproduct requirement to the technical requirements, designing of systemarchitecture, evaluating different technical solutions, etc.
· Participate or lead the following up of theselected ideas within the Emerging Markets Roadmap project or from othersources, implement technology screening in alignment with cross functionaldisciplines, like marketing, medical affairs, etc
·Support tobuild-up system know-how (including technological, application and medical) andprovide it to the teams in PEC.MiD China
1) Main tasks:
·Transfermarketing product requirements and regulatory standard into technicalrequirements, design and document the system architecture, including review andalignment with key stakeholders
·Develop technicalsolution for specific requirements or features, lead the implementation ofpossible technical solutions and evaluate them with reasonable Matrixmethodologies.
·Coordinatethe development activities among different functions (R&D, Verification,R&A, purchase, etc.), such as design review, system integration, projectplanning and so on.
·Be one of theCross Functional Team members within the R&D projects, provide routinestatus to project team and get the feedback
·Supportrelevant product registration activities and provide help as necessary
2) Secondary tasks:
·Build upsystem know how on dialysis machines and the application development andprovide it to other functions in the organization, including solidtechnological know-how, setup and maintenance, and medical scientificbackground
·Developinnovative ideas to fulfil the unmet needs from the market
·Assurecompliance to corporate policies and local standards operating procedures aswell as domestic and international standards
3) Miscellaneous tasks:
Tasks not performed regularly which arenevertheless a distinct part of the job, or special tasks / project work.
·Other tasksassigned by the supervisor
Qualifications, experience, know-how and skillscritical for success*
1) Required training and education:
Master degree or above in engineering orscience; or Bachelor’s with equivalent plus more than 6 years product lifecycle experience with demonstrated results to do system design of complexprofessional instrument, medical device will be a plus
2) Required professional experience (inyears):
·6 years ormore related experience in Medical device industry
3) Important personal qualities:
·Able to workwith people with different cultural and education background
·Self-Initiativeand able to work under certain pressure
4) Other specialized knowledge:
a) Technical knowledge
·Proveneducation regarding Master or Bachelor in Systems, Mechanical, Electrical,Computer Science, Physics or Biomedical Engineering
·Evidence ofpractical knowledge of standards and regulations pertaining to the medicaldevice industry, bothdomestic and international. This includes but is notlimited to organizations such as FDA, IEC, ISO, CFDA
·Demonstratedexperience in product development for complex professional instrument. Medicaldevice is preferred.
·Capability ofSystem Modelling simulation
·Demonstratedexperience in product requirements break-down into systems, subsystems, modulesand/or cross functions.
·Demonstratedexpertise in applying DFx (manufacturability, assembly, serviceability, safety,cost) knowledge to system & sub-systems designs in mechanical, electronics,software/firmware.
·Good writtenand verbal communication skills in English
c) IT skills
·Good word,excel and PPT tool
·Skills inproduct requirement management tools, like DOORs, Polarion, etc
d) Product knowledge
·Experience inMedical device development and relevant regulatory standard, systemarchitecture, working principle, safety design, etc
·Experience inother professional diagnosis instrument and relevant regulatory standard,system architecture, working principle, safety design, etc
·Goodunderstand of the operation environment of the product being developed and itsmarket situation
5 ) Special personal requirements:
Please list requirements such aswillingness to travel or work weekends or shifts etc.
·Excellentcommunication and documentation skills
·Excellentethic with strong ability to work with cross functional/sites teams
·Beingself-initiative and have strong sense of product quality and responsibilities