Systems Engineer

Systems Engineer

Location: Madison, WI

FTE only

Must Have Technical/Functional Skills

• Must possess sound knowledge of systems engineering disciplines and related areas like electro-mechanical systems with software.

• Professionals with Systems Engineering / Reliability certification is preferred

• A demonstrated track record in electromechanical system development, preferably medical devices, and medical grade water devices.

• Proven ability to create results within budget, timeline, and product/project deliverable.

Roles & Responsibilities

• Performs the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post market surveillance.

• Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation. Come up with the recommended mitigation with the rationale.

• Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing priorities.

• Participate in identifying and planning tasks, activities, and resourcing needs related to systems engineering.

• Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability.

• Working knowledge of FMEAs and standards applicable to Systems Engineering.

• Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area.

• Understands clinical and user needs and is able to apply to product realization.

• Creates and maintains Design History File elements.

• Successfully influences stakeholders and cross-functional team members within the project.

• Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.