Software Verification Test Lead

About the Company

Inspire Medical Systems is the pioneer of an FDA-approved medical device designed to reduce the severity of Obstructive Sleep Apnea (OSA) for patients who cannot tolerate or benefit consistently from CPAP. We are committed to enhancing patients’ lives through sleep innovation, prioritizing patient outcomes, acting with integrity, and leading with respect.

Why Join Us

At Inspire, we value diverse experiences, backgrounds, and perspectives. We foster a people-first culture with excellent benefits, 401k matching, an Employee Stock Purchase Plan (ESPP), flexible time off (FTO), and tuition reimbursement. If you’re passionate about making a difference in people’s lives and working with innovative technology, we invite you to join our team.

About the Role

The Software Verification Test Lead is responsible for leading the verification strategy for assigned features or releases, leveraging domain knowledge of the product and state-of-the-art verification practices, including test automation. You will deliver software verification documentation, such as requirement specifications, test plans, test reports, and issue lists. This role involves coordinating test case writing, execution, and issue management while mentoring team members on verification best practices.

Responsibilities

• Establish the verification strategy for features/releases, including test automation, regression analysis, and levels of software testing (unit, integration, and verification).
• Mentor and guide team members in best practices for test case design, test automation, and verification strategies.
• Author Software Verification Test Plans and Reports.
• Provide and manage traceability evidence between requirements, tests, test results, issues, and risk documentation.
• Coordinate cross-functional reviews and approvals of Test Plans and Reports to meet compliance, regulatory, and internal needs.
• Guide resources to deliver quality software products and ensure adherence to requirements and testing processes.
• Drive and monitor formal testing entrance and exit criteria.
• Host regular cross-functional review meetings as part of the software development process.
• Ensure proper regression analysis is performed and scoped to meet risk management objectives.
• Partner with the Project Management Office (PMO) and/or Product Management to keep Software Verification activities on schedule and meet quality objectives.
• Manage issues found during verification activities and drive them to closure.
• Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents as assigned.

Requirements

• Bachelor’s Degree in Engineering, Software, Computer Science, or a related discipline (or equivalent experience).
• 5+ years of experience in software testing, test automation, verification, or software development, including leadership in a matrixed organization.
• Strong written and verbal communication skills, with the ability to engage internal and external stakeholders, including senior leadership.
• Proficiency with MS Office Suite (Word, Excel, Outlook, etc.).
• Familiarity with FDA regulation part 820 and/or standards IEC 13485 / 62304.

Preferred Qualifications

• Advanced degree in Engineering, Software, Computer Science, or a related discipline.
• Experience with Class III medical devices.

Pay

The salary range for this position is $130,000—$190,000 USD, commensurate with the candidate’s experience and qualifications.

Benefits

• Multiple health insurance plan options with employer contributions to a Health Savings Account.
• Dental, vision, life, and disability benefits.
• 401k plan with employer match.
• Identity protection.
• Flexible time off (FTO).
• Tuition reimbursement.
• Employee Assistance Program.
• Equity awards and participation in the Employee Stock Purchase Program (ESPP).