Systems Engineer III

at  Verathon

Company Overview:
Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com.
Overview:
The Systems Engineer III is responsible for serving as system engineering representative and support for one or multiple development projects.

Responsibilities:

• Develops the technical definition of product and system functionality by translating customer and user needs into well-defined product and system specifications.
• Manages the systems architecture documentation for products and subsystems.
• Defines the interface and interaction between the different subsystems.
• Participates and leads Use and Design FMEA risk assessments with cross-functional team.
• Accountable and responsible for creation of System Level Risk Analysis
• Creates Master Validation Plan and Reports
• Supports product Validation and Verification plans.
• Serves as a primary contact across various stakeholder groups in the product development process
• Participates in design and execution of early feasibility studies to better understand design and technical trade-offs and use case constraints.
• Actively participates in end-user formative evaluation studies, assessing impact to design based on the outcome.
• Supports sustaining activities for current products.
• Serves as systems engineering approver on CAPAs and Engineering Change Requests for sustaining programs.
• Supports system engineering and requirements management process improvements within the organization.
• Participates in project planning and ensure assigned tasks are completed according to schedule.

Qualifications:

• Bachelor of Science degree in Engineering or Applied Physics required; Master’s preferred
• 5+ years of technical product development and/or experience collecting and analyzing design inputs and transforming them into use cases, stakeholder requirements, and system requirements.
• P. Eng. Registration with EGBC is required.
• Experience working in electromechanical product development.
• Strong knowledge of medical device Design Controls is preferred.
• Experience in all areas of design, testing, and qualification preferred.
• Experience identifying product functionality and constraints.
• Experience building Risk Management Files per ISO 14971
• Experience in writing technical documents
• Ability to make technical judgments using sound engineering principles and techniques.

• Develops the technical definition of product and system functionality by translating customer and user needs into well-defined product and system specifications.
• Manages the systems architecture documentation for products and subsystems.
• Defines the interface and interaction between the different subsystems.
• Participates and leads Use and Design FMEA risk assessments with cross-functional team.
• Accountable and responsible for creation of System Level Risk Analysis
• Creates Master Validation Plan and Reports
• Supports product Validation and Verification plans.
• Serves as a primary contact across various stakeholder groups in the product development process
• Participates in design and execution of early feasibility studies to better understand design and technical trade-offs and use case constraints.
• Actively participates in end-user formative evaluation studies, assessing impact to design based on the outcome.
• Supports sustaining activities for current products.
• Serves as systems engineering approver on CAPAs and Engineering Change Requests for sustaining programs.
• Supports system engineering and requirements management process improvements within the organization.
• Participates in project planning and ensure assigned tasks are completed according to schedule