ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
WHY JOIN OUR FAST-GROWING TEAM
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
We are recruiting for a Senior Systems Engineer to join our growing product development team located in the Minneapolis, MN location. As an integral part of our development team, you will work closely with our engineering team to develop software for our next generation Inspire products.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
Partners with Marketing, Clinical, Human Factors, Medical Safety, and field-facing teams to translate stakeholder needs, use cases, and use environments into clear system-level design inputs.
Responsible for defining, evaluating, and maintaining system design, functional decomposition, interfaces, operating modes, performance budgets, and key design trade-offs across hardware, software, firmware, disposables, and accessories.
Responsible for the development, review, requirement allocation, and lifecycle management of stakeholder needs, 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 best practices for testing, scalability, and maintainability.
Support and create product risk management (DFMEA and UFMEA) deliverables in compliance with ISO 14971, specifically 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 in partnership within product development, operations, marketing, sales & education
Supports monitoring product performance, complaint investigations, and supports evaluation of quality issues impacting released product
Supports technical problem solving including CAPA investigations and triaging issues.
Demonstrates the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management.
WHAT YOU CAN BRING TO OUR GREAT TEAM
Required:
5+ years (3+ years with Master’s degree) of work experience in systems, software or signal processing
Ability to efficiently specify, design, implement, verify, validate, and support high quality design features
Ability to perform statistical analysis (e.g. distribution identification, capability analysis, statistical comparisons)
Experience developing tools in MATLAB, Python, and C++ languages or equivalent
Bachelor’s degree in biomedical, software, computer science, or related field.
Medical device product development experience
Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, IEC 60601, IEC 62304, IEC 62366 etc.
Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for…