Sr Systems Engineer - Exempt
- Minneapolis, MN
- Permanent
- Full-time
- Collect and analyze design inputs and transform them into high-quality engineering requirements.
- Perform system architecture and design for all phases of system development, including concept, design, fabrication, test, installation, operation, maintenance, and disposal.
- Ensure the logical and systematic conversion of system requirements into product requirements, considering technical, schedule, and cost constraints.
- Conduct 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 architecture definition, interface management, performance modeling, system integration, and design failure modes and effects analyses.
- Identify technical development risks and 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.
- Support regulatory body submissions and facilitate knowledge transfer to continuation engineering teams.
- Represent the organization as a primary contact for specific projects and initiatives, communicating with internal and external customers and vendors at various levels.
- Manage moderately complex projects, involving delegation of work and review of work products, sometimes acting as a team leader.
- Provide guidance, coaching, and training to other employees within the job area.
- Establish and advocate for best practices and continuous improvement to mature the Systems Engineering knowledge and processes.
- 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.
- 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 skills.
- 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 environments.