Sr Systems Engineer

Job Description:

We are seeking a Sr Systems Engineer for a very important client Responsibilities may include the following and other duties may be assigned Collect and analyze design inputs (customer needs, business needs, etc.) and transform them into high quality engineering requirements Perform system architecture and design for all phases of system development to include: concept, design, fabrication, test, installation, operation, maintenance and disposal Ensure the logical and systematic conversion of system requirements and design into product requirements that acknowledge technical, schedule, and cost constraints Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications Lead, coordinate, execute, and document system analysis and design activities including but not limited to architecture definition, interface management, performance modeling, system integration, and design failure modes and effects analyses Identify technical development risks, develop and execute risk burn-down plans Facilitate cross-functional engineering and project team communication to drive design decisions, align on test and integration strategies, review test results, identify technical issues and manage their resolution Verify system requirements have been properly implemented (writing, leveling, tracing) through inspection, demonstration, test or analysis Validate that implemented systems meet customer needs Support regulatory body submissions and facilitate knowledge transfer to continuation engineering teams Represent the organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels May negotiate with others to reach understanding or agreement, and influence decision-making Manage moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader Provide guidance, coaching, and training to other employees within job area Establish and advocate for best practices and continuous improvement as to mature the Systems Engineering knowledge and processes Understand and advocate for technology evolution and participate in the development of system and product roadmaps.

Requirement:

Nice to Have Experience developing system definition, system design and requirements, requirement tracing to subsystems and interface requirements, and system verification and validation strategy and testing Previous medical device experience with a history of developing products from technology to market release Experience with designing for the Hardware/Firmware/communication interfaces of electronic devices Experience in troubleshooting firmware/software interfaces Experience developing sensor-based systems, including closed-loop feedback control systems Experience developing data analytics algorithms, and machine learning algorithms Product Risk Assessment and Risk Management Experience (Fault Tree Analysis, Failure Modes and Effects Analysis, etc.) Experience working with and designing systems to meet ISO and Quality System Regulation requirements, including IEC-60601-1, -2, -6, IEC-62304, ISO-14971, FDA 21CFR820.30 for Class I, II and III medical systems Demonstrated strong verbal/written communication Demonstrated ability to make decisions quickly and guide a team through complex problems Experience working in cross-functional and team environments Experience working in FDA regulated and/or medical device environment Experience interfacing with physician customers and therapy consultants Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience May have practical knowledge of project management Requires a University Degree and minimum of 6 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience.