Software Verification Test Lead

Inspire Medical Systems Inc.•Minneapolis, MN

2d•$130,000 - $190,000•Onsite

About The Position

The Software Verification Test Lead is responsible for leading the verification strategy for assigned features/releases, leveraging domain knowledge about product as well as verification state-of-the-art (including test automation). The software verification test lead will lead in delivering the necessary software verification documentation for assigned releases. Including, but not limited to, requirement specifications, verification test plans, verification test reports, open issues lists and other necessary documents as assigned. You will coordinate and lead efforts for test case writing, test execution, and issue management for their respective assigned release(s). You will mentor team members performing verification activities in verification best practices and state-of-the art including, including, but not limited to good test case and verification design and test automation. You will work cross-functionally with other team members on testing and verification deliverables supporting multiple software development initiatives.

Requirements

Bachelor’s Degree in Engineering, Software, Computer Science, or related discipline or equivalent experience
5+ years of similar experience, including leading software testing, test automation, verification experience and/or software development experience.
Proven ability to effectively lead people in a highly matrixed organization.
Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership.
Proficient with MS Office Suite (e.g., Word, Excel, Outlook, etc.)
Familiarity with FDA regulation part 820 and/or standard IEC 13485 / 62304

Nice To Haves

Advanced level degree in Engineering, Software, Computer Science, or related discipline
Class III medical device experience

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 performing verification activities in best practices regarding testing including, but not limited to, 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 the Test Plans and Reports to meet compliance, regulatory, and internal needs.
Guide resources accordingly to deliver quality software products.
Ensure requirements and testing processes are being followed and coach team members accordingly.
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 correctly to meet risk management objectives for the assigned release(s).
Partner closely with the Project Management Office (PMO) and/or Product Management to keep Software Verification activities on schedule and meet quality objectives. This includes giving input to and/or creating project and resource plans and managing expectations accordingly.
Manage issues found during verification activities and help drive them to closure.
Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned.