Overview
Schedule
Full-time
Education
Engineering (PE)
Career level
Senior-level
Remote
On-site
Benefits
Career Development
Job Description
POSITION SUMMARY
The Software Engineer will work closely with the Digital Solutions teams located in the Minneapolis, MN location. As an integral part of our development team, this position will work closely with our engineers and scientists to develop applications for our next generation Inspire products.
MAIN DUTIES/RESPONSIBILITIES
- Build and deploy cutting edge patient management and support services on Azure using .NET Core, C#, Python, and/or other supporting languages
- Assist with system, software, security, and risk management documents
- Test, debug, and document integration solutions and enhance existing components to ensure that software meets the business needs, while in compliance with applicable regulations and processes (IEC 62304)
- Assure compliance with industry applicable standards for medical devices
- Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery
- Create, control, and store software source and executable code 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.
QUALITY SYSTEM RESPONSIBILITIES
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
QUALIFICATIONS
Educational Requirements: Bachelor's Degree in Engineering, Software, Computer Science, or related discipline
Required Experience:
- 2-4 years' experience with .NET development in C# or similar object-oriented language
- Experience with Azure deployment tools and build processes for downloadable software
- Familiarity with Software as a Medical Device (SaMD) regulations such as IEC 62304 or IEC 82304-1, ISO 13485
- Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior department leadership
- Familiarity with FDA regulated software verification best practices
Preferred Experience:
- Advanced level degree in Engineering, Software, Computer Science, or related discipline
- Experience working on Agile development teams and best practices
- Familiarity with reviewing peer's code in a collaborative development team
- Medical device development cycle experience
- Authorship of QMS / FDA regulated software documentation
#LI-Onsite
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FAQs About Software Engineer - Medical Device Software Jobs at Inspire Medical Systems, Inc.
What is the work location for this position at Inspire Medical Systems, Inc.?
This job at Inspire Medical Systems, Inc. is located in Minneapolis, MN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Inspire Medical Systems, Inc.?
Employer has not shared pay details for this role.
What employment applies to this position at Inspire Medical Systems, Inc.?
Inspire Medical Systems, Inc. lists this role as a Full-time position.
What experience level is required for this role at Inspire Medical Systems, Inc.?
Inspire Medical Systems, Inc. is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What benefits are offered by Inspire Medical Systems, Inc. for this role?
Inspire Medical Systems, Inc. offers Career Development for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Inspire Medical Systems, Inc.?
You can apply for this role at Inspire Medical Systems, Inc. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.