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Inspire Medical Systems

FDA-approved neurostimulation device for OSA

Senior Systems Engineer

Biomedical Engineering & Medical DevicesPosted on Nov 10
Full-timeMinneapolis, MN, USA

About the Job

Requirements

  • At least 5 years of work experience in systems, software, or signal processing, or at least 3 years with a master's degree.
  • Ability to specify, design, implement, verify, validate, and support high-quality design features.
  • Ability to perform statistical analysis, including distribution identification, capability analysis, and statistical comparisons.
  • Experience developing tools in MATLAB, Python, and C++ or equivalent languages.
  • Bachelor's degree in biomedical, 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.

Responsibilities

  • Partner 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.
  • Define, evaluate, and maintain system design, functional decomposition, interfaces, operating modes, performance budgets, and key design trade-offs across hardware, software, firmware, disposables, and accessories.
  • Develop, review, allocate, and manage the lifecycle of 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 best practices for testing, scalability, and maintainability.
  • 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 in partnership with product development, operations, marketing, sales, and education.
  • Monitor product performance, investigate complaints, and evaluate quality issues impacting released product.
  • Support technical problem-solving, including CAPA investigations and issue triage.
  • Communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels, and external customers to pursue product quality improvements and post-market risk management.

Desired Qualifications

  • 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 a related field.

About the Company

Inspire Medical Systems

FDA-approved neurostimulation device for OSA

Inspire Medical Systems develops and sells a minimally invasive implantable device for obstructive sleep apnea (OSA). Its lead product, the Inspire system, uses implanted neurostimulation to activate the hypoglossal nerve, which moves the tongue and other airway muscles to keep the airway open during sleep. Patients control the therapy with a small handheld remote. The system targets adults with moderate to severe OSA who cannot use or benefit consistently from CPAP. Unlike non-implant options, Inspire provides a hands-free, on-demand airway support during sleep and is the first FDA-approved neurostimulation treatment for OSA. The company differentiates itself by offering a clinically approved implantable alternative to CPAP, backed by a direct US sales force and a network in Europe. Its goal is to provide an effective, durable option for patients who struggle with CPAP, expanding access to neurostimulation therapy to improve sleep quality and health outcomes.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Golden Valley, MN
Founded
2007

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