Job #2337: We are currently looking for a Sr Systems Engineer in Kirkland, WA to join our team on a long-term project for new product development projects.  This role will be heavily involved in cross-functional Product Definition and Risk Analysis as part of the Embedded Software Development team.  The objective of the team is to develop safe, reliable, soft and hard real-time software components that meet customers’ needs.

The Sr Systems Engineer will interact with Software, Electrical, and Mechanical engineering disciplines, as well as customers, and customer advocates to understand the intended software component uses.  They are directly responsible for the development, review and ongoing maintenance of high quality, well understood, broadly communicated component requirements and are expected to become knowledgeable in relevant subject matter.

The Sr Systems Engineer has primary responsibility for Software Failure Analysis and Risk Mitigation development to help drive design improvements.  They also play a key role in software component verification planning and development/review of automation protocols.  As an integrated member of the Embedded Software Development team it is important the candidate have in-depth knowledge of Computer Systems engineering.

MAJOR RESPONSIBILITIES:

  • Lead and/or contribute to cross-functional definition teams to capture cohesive, holistic requirements and/or specifications of software components used in a medical device
  • Lead the documentation, review, communication and maintenance of assigned areas of Software Requirements Specification and associated Traceability
  • Lead Software Component Failure Analysis activities in assigned areas
  • Work directly with embedded development team to translate System Requirements and System Risk Analyses into component-level requirements, designs and risk management approaches
  • Support Software Component Verification planning, protocol development and reporting, as required
  • Analyze system problems and determine root cause
  • Other related duties as assigned

BASIC QUALIFICATIONS:

  • 5 or more years with B.S.; 3 – 5 years with M.S.
  • Direct experience with definition and documentation of Engineering requirements
  • Direct, practical experience with at least two of the following areas: Systems Engineering, Class 2 or Class 3 Medical Device Safety and Compliance Standards, Medical Device Risk Analysis, DOORS usage for requirements and traceability.
  • Excellent verbal and written documentation and communication skills
  • Strong attention to detail
  • Passion for defining and delivering high-quality products that satisfy users’ needsDESIRED/PREFERRED QUALIFICATIONS:
  • Electrical engineering and/or Software development background
  • Knowledge of IEC 60601-series medical device safety standards
  • Exposure to clinical usage of medical devices for emergency medicine, electrophiosiology and/or cardiac rhythm management
  • Software development expertise, direct programming experience a plus, and/or comfort reading C/C++ and PythonWORKING CONDITIONS:
  • Office environment, significant computer usage, extended hours as needed, occasional travel

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