Senior Systems Engineer Job Posting

Posted on September 26, 2016

THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:

  • BS in Electrical, Mechanical or Computer Science Engineering w/ minimum of 8-10 yrs. experience in an interdisciplinary product development environment or a Masters Degree in Electrical, Mechanical, or Computer Science Engineering w/ minimum of 5-8 years of experience in an interdisciplinary product development environment
  • Demonstrated competency in program planning, e.g. developing work breakdown structures, resource planning
  • Thorough understanding of requirements management; from development through verification and validation; experience with requirements management tools
  • Working knowledge of ISO 14971 and/or experience in conducting safety risk management activities, e.g. Hazard Analyses, FTA, and FMEA
  • Experience in the development of the product/system architectures
  • Working knowledge of safety compliance process (product safety marks)
  • Experience in the conduct of Design Verification activities
  • A minimum of 1-2 years of this experience in a SE role while operating under a registered QS or FDA QSR


THE FOLLOWING IS DESIRED, BUT NOT REQUIRED TO BE CONSIDERED FOR THIS POSITION:

  • Working knowledge of Design Validation activities
  • Experience in supporting marketed products
  • Working knowledge of device clinical trials (from the device perspective)
  • Familiarity of applicable EU New Approach Directives, e.g. MDD, IVDD and pending regulations
  • Familiarity of regulatory submissions, e.g. FDA 510(k), CE Marking
  • Familiarity of available industry reference resources, e.g. AAMI, RAPS, INCOSE
  • US Citizenship or Permanent Resident

 

Please contact us to apply!

 

CMD MedTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.