Kforce Technology

Principal Software Systems Engineer

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Job Description

RESPONSIBILITIES:

Kforce has a client that is seeking a Principal Software Systems Engineer in San Clemente, CA. Summary: The Principal Software Systems Engineer role will be an individual contributor in the team defining and maintaining software system requirements for infusion pumps. This role will execute key design engineering activities to support new product development and on-market engineering projects for the product. This role will also participate in the definition and implementation of improvements in the Systems Engineering design processes and tools. This is a senior engineering role that is expected to be highly experienced in the development and maintenance of secure networked medical products. This role will be expected to mentor less experienced Systems Engineers to encourage their development in the area. This role will be accountable for timely delivery of multiple major engineering deliverables and projects. Essential Duties & Responsibilities

  • Delivery of some Software Systems Engineering portions of the Design History File
  • Work with the Risk Management Team to help build and maintain the Risk Management File
  • Participate in the maintenance of the risk management and testing traceability
  • Support the timely completion of product releases and design changes
  • Contribute to the improvement of engineering design methods and processes
  • Support FDA and other regulatory audits of product design history and technical files
  • Work on special projects as they arise

Job Requirements:

REQUIREMENTS:

  • Bachelor’s degree in Software Engineering from an accredited College or University
  • Advanced degree in related fields is preferred
  • Minimum of 10 years of experience in software development with at least
  • 5 years of previous hands-on programming or electro-mechanical and software experience
  • 2 years of experience in requirements management
  • 3 years working on medical devices or similar industries with high regulatory burdens such as aerospace or defense
  • Experience with infusion pump user interface design
  • Experience with infusion pump clinical workflows
  • Experience with networking is a plus
  • Experience with cybersecurity is a plus
  • Experience in Software Development using a modern programming language such as Java/ C#/C++ is a plus
  • Experience working on the architecture of an embedded medical device required
  • Experience developing product requirements and design inputs required
  • Experience with UML and/or SysML required
  • Experience with MBSE using tools such as Magic Draw or similar is a plus
  • Experience with hazard analysis and assurance cases is a plus

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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Job Summary

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San Clemente, California Location
Permanent Job Type
Kforce Technology