Sr. Systems Engineer

Inspire Medical Systems Inc.•Minneapolis, MN

17h•$130,000 - $170,000•Onsite

About The Position

Inspire Medical Systems is recruiting a Senior Systems Engineer for its product development team in Minneapolis, Minnesota. The role works closely with engineering and cross-functional teams to develop software and next-generation Inspire products. The engineer translates stakeholder needs, use cases, and use environments into system-level design inputs, and defines and maintains system design, functional decomposition, interfaces, operating modes, performance budgets, and design trade-offs across hardware, software, firmware, disposables, and accessories. The position develops and manages stakeholder needs and system and product requirements, with particular attention to interface and performance requirements, clarity, testability, consistency, and traceability. It contributes to or leads technical and design reviews, supports risk management and design transfer, and assists with product launches, post-market performance monitoring, complaint investigations, quality issues, CAPA investigations, and issue triage. The role also communicates and collaborates with internal cross-functional teams, leaders, and external customers on product quality and post-market risk management.

Requirements

At least 5 years of work experience in systems, software, or signal processing; 3 or more years with a master's degree.
Ability to efficiently specify, design, implement, verify, validate, and support high-quality design features.
Ability to perform statistical analysis, such as distribution identification, capability analysis, and statistical comparisons.
Experience developing tools in MATLAB, Python, and C++ or equivalent languages.
Bachelor's degree in biomedical engineering, software, computer science, or a related field.
Medical device product development experience.
Experience with medical device industry standards such as ISO 14971, ISO 14708, EN 45502, IEC 60601, IEC 62304, and IEC 62366.
Understanding of 21 CFR 820 and ISO 13485 requirements for design, development, and manufacturing.

Nice To Haves

Understanding of systems engineering processes and practices.
Understanding of mechanical, electrical, and embedded signal processing algorithms for physiologic signals.
Understanding of software and systems considerations for clinical research.
Master's degree in biomedical engineering, software, computer science, or a related field.

Responsibilities

Partner with Marketing, Clinical, Human Factors, Medical Safety, and field-facing teams to translate stakeholder needs, use cases, and use environments into system-level design inputs.
Define, evaluate, and maintain system design, functional decomposition, interfaces, operating modes, performance budgets, and design trade-offs across hardware, software, firmware, disposables, and accessories.
Develop, review, allocate, and manage stakeholder needs and system and product requirements, particularly interface and performance requirements, ensuring clarity, testability, consistency, and end-to-end traceability.
Contribute to or lead design and technical reviews to ensure designs meet or exceed design inputs and follow testing, scalability, and maintainability best practices.
Support and create product risk management deliverables, including DFMEA and UFMEA, in compliance with ISO 14971, providing technical input on system-level effects.
Support design transfer activities to ensure the design has been properly transferred to manufacturing.
Support new product launch planning with product development, operations, marketing, sales, and education.
Support monitoring product performance, complaint investigations, and evaluation of quality issues affecting released products.
Support technical problem solving, including CAPA investigations and issue triage.
Communicate, influence, and negotiate with internal cross-functional employees, leaders, and external customers to pursue product quality improvements and post-market risk management.