1+ months

Systems Engineer

Boston, MA

Systems Engineer

In our CPS R&D Hematology & Coagulation organization we develop a new product family of fully automated and highly innovative analyzers providing significant medical value and superior testing efficiency to our customers.

In our Boston office location, we are working to develop the worldâs first integrated hematology instrument, which combines a digital image-based cell locator, a cell classifier, and a cell counter with its own slide maker and stainer.

Job Responsibilities:

  • Maintain knowledge of state-of-the-art principles, theories, and practices around all systems engineering related activities. Identify and recommend long-term tools, standards, and methods to drive continual systems engineering improvement.
  • Proficient in the use of systems engineering tools and processes. Familiar with Design Control process requirements.
  • Draft work instructions (WI), SOPs, engineering reports, drawings and necessary documentation in order to release design changes.
  • Provide support through analytical data collection and data analysis. Develop data analysis tools, GUIs in a programming language such as Phython, Perl etc.
  • Designs, defines, implements and / or tests complex system requirements; develops integrated solutions in consideration of scientific, engineering, manufacturing and service disciplines.
  • Analyze complex, multi-disciplinary technical issues encountered during the operation and use of instruments.  Develop, test, recommend and implement corrective actions to address these issues.
  • Develop complete system analyses and models that will predict how an instrument, or a particular subsystem, as the case may be, will perform under a variety of conditions so as to optimize designs and/or operating parameters from a cost/performance/reliability viewpoint.
  • Provide hands-on support for various engineering aspects of the project, perform feasibility studies for proposed design, systems or processes and prepare technical presentations to development team
  • Participates in Cross-Functional Teams in efforts relating to system requirements definition, system functional decomposition and requirements allocation, system architecture definition, system modeling, and requirements traceability and compliance including verification plans and reports.
  • Maintain knowledge of state-of-the-art principles, theories, and practices around all systems engineering related activities. Identify and recommend long-term tools, standards and methods to drive continual systems engineering improvement.
  • Collaborates with global support and complaint investigation teams on the creation of potential usable "workarounds" in support of keeping customers operational, during long complex investigations.
  • Ensure compliance to FDA QSR, ISO 13485, ISO 14971, and other applicable regulatory requirements.

Youâre someone who wants to influence your own development. Youâre looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

To be successful in this role you have to bring following skill set / experiences:

  • Bachelor of Science Degree in Engineering (ME, EE, or BE) or Science-related field
  • Demonstrated experience with development of complex instrumentation.
  • Strong engineering, software programming, analytical, troubleshooting and testing skills.
  • Experience in writing product requirements, specifications, test protocols, and test reports.
  • Experience in medical device industry.
  • Experience working with HP-ALM and DOORS requirements management tools.
  • Experience in common risk management techniques (FMEA, FTA, ETA).
  • Knowledge/experience with data analysis, statistics, programming, electro-mechanical systems and automation.
  • Strong communication and collaboration skills
  • Willingness to travel to various project sites
  • Self-starter and self-motivated
  • Ability to work in a cross-functional team
Posted: 2018-10-11 Expires: 2018-12-27

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Systems Engineer

Boston, MA

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