Sr Systems Engineer

Job Title - Sr Systems Engineer

Job Location - Minneapolis, Minnesota,

Job Description

Responsibilities may include the following and other duties may be assigned.

• Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems.
• Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal.
• Ensures the logical and systematic conversion of product requirements into total systems solutions 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.

Requires a University Degree and minimum of 6 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience.

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.

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.