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Inspire Medical Systems

FDA-approved neurostimulation device for OSA

Software Engineer - Medical Device Software

Backend EngineeringConfirmed live in the last 24 hours
Full-timeMinneapolis, MN, USA

About the Job

Requirements

  • A bachelor's degree in Engineering, Software, Computer Science, or a related discipline is required.
  • Two to four years of experience with .NET development in C# or a similar object-oriented language is required.
  • Experience with Azure deployment tools and build processes for downloadable software is required.
  • Familiarity with Software as a Medical Device regulations such as IEC 62304 or IEC 82304-1, and ISO 13485, is required.
  • Strong written and verbal communication skills to communicate with internal and external stakeholders and senior department leadership are required.
  • Familiarity with FDA-regulated software verification best practices is required.

Responsibilities

  • Build and deploy patient management and support services on Azure using .NET Core, C#, Python, or other supporting languages.
  • Assist with system, software, security, and risk management documents.
  • Test, debug, and document integration solutions, and enhance existing components to meet business needs while complying with applicable regulations and processes, including IEC 62304.
  • Assure compliance with industry standards applicable to medical devices.
  • Ensure quality system, regulatory, legal, and business requirements are met during product development and market delivery.
  • Create, control, and store software source and executable code, and support Inspire customers as assigned.
  • Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.
  • Develop, disclose, and support the patenting of innovative technology and solutions.
  • Document product- and therapy-related field reports within prescribed timelines and provide documents needed to complete investigations; provide follow-up reporting as needed.
  • Complete required training and competency confirmations within required timelines.
  • Comply with applicable quality system procedures and policies, and suggest continuous process improvements.

Desired Qualifications

  • An advanced-level degree in Engineering, Software, Computer Science, or a related discipline is preferred.
  • Experience working on Agile development teams and knowledge of Agile best practices are preferred.
  • Familiarity with reviewing peers' code in a collaborative development team is preferred.
  • Medical device development cycle experience is preferred.
  • Authorship of quality management system or FDA-regulated software documentation is preferred.

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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