Principal Systems Engineer

Employment Type

: Full-Time

Industry

: Miscellaneous



Description

The PrincipalEngineer, Systems Engineering role will be an individual contributor in theteam defining and maintaining software system requirements for ICU Medical’sinfusion pumps. This role will execute key design engineering activities tosupport new product development and on-market engineering projects for theproduct. This role will also participate in the definition and implementationof improvements in the Systems Engineering design processes and tools.

This is asenior engineering role that is expected to be highly experienced in thedevelopment and maintenance of secure networked medical products. This rolewill be expected to mentor less experienced Systems Engineers to encouragetheir development in the area. This role will be accountable for timelydelivery of multiple major engineering deliverables and projects.

Essential Duties & Responsibilities

  • Delivery of some Software Systems Engineering portions of the DesignHistory File
  • Work with the Risk Management Team to help build and maintain the RiskManagement File
  • Participate in the maintenance of the risk management and testingtraceability
  • 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 andtechnical files
  • Work on special projects as they arise
  • Knowledge, Skills &Qualifications

  • Experiencewith infusion pump user interface design
  • Experiencewith infusion pump clinical workflows
  • Experiencewith networking is a plus
  • Experiencewith cybersecurity is a plus
  • Experiencein Software Development using a modern programming language such as Java/C#/C++ is a plus
  • Experienceworking on the architecture of an embedded medical device required
  • Experiencedeveloping product requirements and design inputs required
  • Experiencewith UML and/or SysML required
  • Experiencewith MBSE using tools such as Magic Draw or similar is a plus
  • Experiencewith hazard analysis and assurance cases is a plus
  • Education and Experience

  • Minimumof 10 years of experience in software development with at least
  • 2years of experience in requirements management
  • 5years of hands-on programming experience
  • 3years working on medical devices or similar industries with high regulatoryburdens such as aerospace or defense
  • Bachelor’sdegree in software engineering from an accredited college or university
  • Advanceddegree in related fields is preferred
  • Minimum Qualifications

  • Must be at least 18 years of age
  • TravelRequirements

  • Typically requires travel less than 5% of the time
  • Physical Requirements and WorkEnvironment

  • Thisis largely a sedentary role.
  • Thisjob operates in a professional office environment and routinely uses standardoffice equipment.
  • Physical Requirements and WorkEnvironment

    Whileperforming the duties of this job, the employee may be required to sit or standfor long periods of time; depending on the machine they are operating

    Operator isrequired to use computer or touch screen to enter work order data

    Must be ableto occasionally move and lift objects of up to 25 lbs.

    ICU Medical isan Affirmative Action and Equal Opportunity Employer. All qualified applicantswill receive consideration for employment without regard to race, color,religion, sex, sexual orientation, gender identity, national origin, orprotected veteran status and will not be discriminated against on the basis ofdisability.


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