Sr. Systems Engineer
Inspire Medical Systems Inc.
Summary
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.
Job description
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 design, development and manufacturing
Preferred
- 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, software, computer science, or related field
Requirements
- 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 design, development and manufacturing
- 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, software, computer science, or related field
Benefits
- Health Insurance
- Health Savings Account
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Benefits
- 401(k) Matching
- Identity Protection
- Flexible Time Off
- Tuition Reimbursement
- Employee Assistance Program
- Equity Awards
- Employee Stock Purchase Program
Company overview
Inspire Medical Systems Inc. is a pioneering medical technology company founded in 2007 and headquartered in Golden Valley, Minnesota. The company specializes in developing and commercializing innovative neurostimulation solutions for treating obstructive sleep apnea (OSA). Inspire's flagship product is the Inspire Sleep Apnea System, the world's first FDA-approved fully implanted neurostimulation device for moderate to severe OSA treatment. This revolutionary technology uses proprietary algorithms to stimulate key airway muscles based on individual breathing patterns, offering a mask-free alternative to traditional CPAP therapy. As a publicly traded company (NYSE: INSP) with over 1,200 employees, Inspire has established significant market presence in both the United States and Europe, generating substantial revenue growth. The company maintains strong relationships with healthcare providers and federal agencies, including the Department of Veterans Affairs and Defense Health Agency, while continuously advancing its technology through research and development. Inspire's patient-centric approach and commitment to improving quality of life have positioned it as a leader in sleep disorder treatment innovation.