Senior Staff Systems Engineer

JOB DUTIES:

Responsible for the systems engineering function for our complex medical
devices. Work with the technical processes of medical device systems engineering to cover the
whole system life cycle, which includes conceptualizing/planning, determining stakeholder
needs and requirements, creating systems requirements, creating system architecture
(spanning across electrical, firmware, and mechanical disciplines), designing features spanni
across multiple disciplines, analyzing requirements (clarity, implementable, testable, etc.),
implementation (working with design software to execute requirements), performing system
integration analysis and testing, and performing verification & validation (V&V). Collaborate wi
cross functional teams to ensure system requirements and complex system interactions will
appropriately be met. Duties include: Participate in product definition, system architectur
requirements writing, requirements management, requirements analysis, risk analysis, hazard
analysis, product test and evaluation, System V&V, and design control documentation; Gather
and analyze input/output requirements from stakeholders for new medical devices and device
features and translate information into specific system features; Contribute to project planni
to explore product or process problems, define and select new concepts and approaches
the design or development of new or improved products or processes; Generates and applies
literature, patents, and current practices to solve issues and synthesize all gathered information
together with technical and regulatory constraints to define a system and the system behavio
resulting in a system specification; Evaluate prototypes formally and informally throu
structured and ad hoc testing, test aspects of new projects or algorithms to evaluate
prototypes and validate output to meet intended requirements and collect, organize, analyze,
and document test results; Collaboratively plan, design, develop, troubleshoot/debug and drive
integration at the intersection of software, hardware, mechanical, and research within our
complex systems; and, Coach and mentor engineers, providing design guidance and driving
best practices. Utilize the following tools and technologies to perform the above duties:
Management tools such as Jama, WindChill, Teamcenter, Innoslate, or Excel; EDA software
similar or equivalent to Altium, OrCAD Capture/layout, PADS, etc. for system design, materials
management and generating output files; Python and MATLAB to perform data extractio
analysis and simulation of system performance; Project management/collaboration tools
include Jira, Excel, Teams/Zoom/Slack; and, Communication/Analysis tools MS Office su
tools like Word, Excel, and PowerPoint. 

REQUIREMENTS:

Bachelor’s degree in Electrical Engineering, Computer Engineering,
Computer Science, Software Engineering, or related fields and three (3) years of experience
a Systems Engineer or a related role including: working with the technical processes of medical
device systems engineering to cover the whole system life cycle, including
conceptualizing/planning, determining stakeholder needs and requirements; creating system requirements and architecture; designing features spanning across multiple engineering
disciplines; analyzing requirements and performing implementation working with design
software to execute requirements; performing system integration analysis and testing; and,
performing verification & validation (V&V). Requires medical device development including
regulatory compliance, design controls, and change management, systems engineering
principles (e.g., risk management).