Systems Engineer III

Overview

Verathon® is looking for a Systems Engineer III to become the newest member of our Ultrasound R&D team located in Bothell, WA. This role is expected to work primarily on-site at our Bothell facility working with a global team including Canada and Europe. This team member will support the system requirements and architecture for a program targeted at improving patient outcomes by bladder volume measurement.

The Systems Engineer III is responsible for defining and documenting the technical foundation of new product development programs. This includes translating user and stakeholder needs into quantifiable system requirements, creating system architecture and subsystem interfaces definition, managing requirements traceability, and ensuring designs meet regulatory compliance standards. Utilizing Verathon's NPD process and Quality Management System, the Systems Engineer III serves as the key contributor for system-level design decisions and a primary interface between clinical/marketing stakeholders and engineering teams throughout the product development lifecycle.

Responsibilities

•    Contribute with technical expertise in the area of requirements development and verification processes that follows stringent compliance to FDA and other regulated bodies•    Create systems architecture documentation for products to ensure proper subsystem definition and interfaces•    Support FMEA and other system risk assessments in collaboration with design engineers and human factors/marketing teams•    Manage product requirements input and traceability using a requirements management tool (JAMA) •    Interact with clinical and marketing teams on development and translation of user and stakeholder inputs to system (product) requirements for use by development teams•    Effectively collaborate with engineers, program managers, marketing, and business leaders on system level issues•    Support product validation and verification strategies •    Serve as primary contact for system level designs across various stakeholder groups in the product development process•    Support change analyses from a system’s perspective for current product portfolio based on field complaints and continuous improvement efforts•    Participate in project planning by providing timelines for systems deliverables, ensuring  assigned tasks are completed on schedule •    Support and mentor junior engineers, reviewing their work for accuracy and completeness •    Support continuous improvement initiatives for Systems Engineering procedures and contribute to related process changes

Qualifications

•    Bachelor of Science degree in Engineering or Applied Physics is required; Master’s degree or equivalent work experience may substitute for years of experience•    Excellent written and verbal communication skills with the ability to translate complex technical concepts for diverse audiences; strong interpersonal and collaboration skills to build effective working relationships across engineering, clinical, regulatory, and business teams•    5+ years of technical product development•    Experience in all areas of system level design, testing, and qualification•    Experience identifying product functionality and constraints•    Experience performing risk analyses  •    Experience in writing technical documentation•    Experience with Systems Engineering standards such as INCOSE •    Experience with Medical Device Development and Risk Management standards such as ISO 13485 and ISO 14971 is preferred•    Ability to define project goals and delivery dates to meet deadlines in a fast-paced environment•    Ability to make independent decisions using sound judgment, engineering principles, and techniques•    Travel up to 15% of the time is required including out of country •    Experience with requirements management tools (JAMA preferred) and project management tools (JIRA); familiarity with Microsoft Suite and ERP Systems

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