Systems Engineer IV

Note: This is not a netwrok IT admin type role - please review description carefully

Provides technical leadership to small or medium sized project teams to ensure interdisciplinary integration is met. This position is responsible for considering the complete problem across the entire lifecycle of the product. These responsibilities include:
??? Defining customer needs and required product functionality.
??? Documenting product requirements and project constraints.
??? Leading, guiding, and/or performing the technical product development for the system or subsystem being developed-providing and supporting the big picture systems view. This includes tracking key technical metrics to measure margins and risk.
??? Overseeing and leading verification and validation planning, execution, and reporting efforts.
??? Navigating or supporting the team and the product through regulatory compliance activities.
??? Ensuring efficient and complete transition from design into production.
??? Prepares and presents documentation to clients and stakeholders.

This position is also tasked with supporting our business development efforts including writing proposals, planning technical aspects of projects, developing our capabilities, interfacing with current and prospective clients, and participating in conferences.

The Following Is Required
??? Bachelor's Degree in engineering discipline relevant to product development.
??? 5+ years of experience in new product development roles, 3+ years of systems engineering experience
??? Demonstrated track record of successful product development on dynamic projects.
??? Proven abilities in leading cross functional technical teams, managing risk, and adapting to change.
??? Self-motivated, organized, and a problem solver who demonstrates knowledge of fundamentals but also the big picture.
??? Excellent communication skills to support interaction with cross-functional team members, internal management, and clients.
??? Requires US persons as defined by US export control laws.

THE FOLLOWING IS DESIRED
??? An advanced degree in Engineering, Science, or Business.
??? Experience working under an ISO 13485 registered quality system.
??? Experience registering products through FDA regulations (such as 510(k)).
??? Experience with ISO 14971 and/or experience in conducting safety risk management activities (e.g. Hazard Analyses, FTA, and various FMEAs).
???Experience with Model Based Systems Engineering/Design
???Experience with engineering simulation techniques
???Experience with IEC 63266 and/or formative usability testing techniques