Senior Systems Engineer

Verathon, Inc.•Bothell, WA

16d•$149,061 - $184,716•Onsite

About The Position

Verathon® is looking for a Senior Systems Engineer to become the newest member of our Urology 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 establish the system requirements and architecture for an exciting new program targeted at improving patient outcomes in a urological endoscopy procedure - offering the opportunity to shape a product from concept through commercialization within Verathon's established new product development framework. The Senior Systems Engineer is responsible for defining and architecting the technical foundation of new product development programs. This includes using AI to translate user and stakeholder needs into quantifiable system requirements, establishing system architecture and subsystem interfaces, managing requirements traceability, and ensuring designs meet regulatory compliance standards. Utilizing Verathon's NPD process and Quality Management System, the Senior Systems Engineer serves as the technical authority for system-level design decisions and the primary interface between clinical/marketing stakeholders and engineering teams throughout the product development lifecycle.

Requirements

Bachelor of Science degree in Engineering or Applied Physics is required; Master’s preferred
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
8+ 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
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

Nice To Haves

Experience with Medical Device Development and Risk Management standards such as ISO 13485 and ISO 14971 is preferred

Responsibilities

Enable transformation of R&D team to drive rapid growth and challenge norms resulting in improved product outcomes.
Contribute with deep 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
Conduct FMEA and other system risk assessment collaborations
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
Provide mentorship for junior engineers and review their work for accuracy and completeness
Modify established Systems Engineering procedures and drive related continuous improvement initiatives