Inspire Medical Systems · 3 weeks ago
Sr. Software Design Assurance Engineer
Minneapolis, MN
Full-time
Onsite
Senior Level
$108K/yr - $160K/yr
5+ years expInspire Medical Systems is revolutionizing the sleep industry with its FDA-approved medical device aimed at reducing Obstructive Sleep Apnea severity. The Sr. Software Design Assurance Engineer will be responsible for product software quality assurance support, ensuring design control requirements are met, and providing technical direction on quality and compliance throughout the product lifecycle.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Partner with Development to generate project deliverables and conduct audits of the deliverables prior to product release
Ensure design history content integrity, completeness, and regulatory / standards compliance; Collaboratively communicating & resolving gaps with cross-functional team members
Provide product software design assurance services, including planning for software design validation, design transfer, test system development and validation., Including active cross-functional root-cause analysis investigation and resolution
Partner with Development on the validation of software test environments and software tools, including test methodology, test protocol and acceptance criteria development
Support risk management activities from product concept through commercialization
Product expertise and guidance on global medical device software and security standards or other specific industry standards to ensure compliance with those standards. Lead and document standard updates and compliance reviews at the prescribed frequency
Provide quality engineering support for design changes, sustaining engineering projects and when applicable supplier changes
Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
Ensure quality system procedural requirements and development life cycle phases are followed
Ensure proper cyber security testing and controls are utilized and documented
Generate and/or approve the following: DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents and Device Master Record (DMR) deliverables
Provides project direction, coaching, and mentoring for engineering and technical team personnel to ensure best-in-class Software Design Quality Engineering practices
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Support both internal and external audit activities
Support other quality projects and initiatives as assigned
Qualification
Required
Associates degree in a technical or scientific field
5 years minimum experience with medical device software quality or software design assurance role for finished medical devices
Comprehensive knowledge on medical software device design standards along with global regulations for medical device software design
Demonstrated team leadership skills and ability to prioritize, execute and report on projects
Knowledge on medical device data systems (MDDS)
Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA
Knowledge on ISO and FDA/Quality System Requirements. (e.g., ISO 13485; ISO 14969; IEC 62304, FDA 21 CRF Part 820, 821, 822)
Experience working with HIPPA and GDPR
Strong project and time management skills
Ability to work on multiple tasks concurrently with changing priorities
Proficient with of MS Word, Excel and PowerPoint
Experience with Class III active implantable products
Preferred
Experience in software design reliability, process and product quality assurance functions
ASQ certifications; CSQE, CRE, CQM, CQE, etc
Experience working with bug tracking tools such as JIRA
Experience with GHTF requirements for process validations, etc
Bachelor's degree in a technical or scientific field
Benefits
Multiple health insurance plan options.
Employer contributions to Health Savings Account.
Dental, Vision, Life and Disability benefits.
401k plan + employer match.
Identity Protection.
Flexible time off.
Tuition Reimbursement.
Employee Assistance program.
All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
Company
Inspire Medical Systems
Inspire Medical Systems develops implantable therapeutic devices for the treatment of obstructive sleep apnea.
1001-5000 employees
H1B Sponsorship
Inspire Medical Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (2)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$319.4MKey Investors
Amzak Capital ManagementOrbiMedMedtronic
2020-04-13Post Ipo Equity· $133.4M
2018-12-18Post Ipo Equity· $75M
2018-05-03IPO
Leadership Team
Tim Herbert
Chairman & CEO
Richard Buchholz
CFO
Recent News
2026-01-07
2026-01-06
Company data provided by crunchbase