Software Verification Engineer

Title: Software Test EngineerLocation: Plymouth, MNDuration: 6 Months with possibilities of extensionTiming: 8 AM - 5 PMConversion to FTE (Based on Budget & Candidate Performance)Relocation is fine. Local candidates are highly preferred Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered Description:Client is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional’s and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.WHAT YOU’LL DOThe Software Test Engineer will provide technical leadership and cross-functional influence within a vibrant, high-performing R&D team that is redefining the treatment of structural heart disease. The incumbent will lead the software test workstreams across a product and non-product ecosystems involving multiple devices, and fill other roles/responsibilities to meet evolving business needs as directed by management.REQUIRED QUALIFICATIONSBachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering or similar (ABET preferred).Minimum 2 years of relevant experience.Experience in C/C++ family of coding languages, Ability to read C/C++ (C# exposure helpful).Familiarity in common software test methodologies identified in IEC 62304 such as unit, integration, verification and software system testing.Experience in non-product software validation compliant with FDA 21 CFR Part 820, EU-MDR regulations, and ISO 13485. Familiarity with implementation of static and dynamic unit test tools and methods. Familiarity with common code repositories and maintenance thereof. Ability to work with software developers to produce concise, unambiguous software design/test documentation.High motivation, technical curiosity and inclination to find creative ways forward when faced with challenges.Hands-on lab testing experience and strong documentation/report writing skills Strong communication, initiative, and ability to thrive in fast-paced Agile environmentPREFERRED QUALIFICATIONSAdvanced degree (Master’s or PhD) in Computer Science, Data Science, Physics or Engineering. Experience in first-in-human and pivotal clinical trials. Experience and/or familiarity with cardiac anatomy and interventional cardiology.GUI experience (QT framework preferred but not required).Python (nice-to-have).Linux familiarity.Additional Requirements:Industry: Medical device experience preferred but not required.Systems: Windchill (documentation), Jira (Agile backlog/tools).Traits: Proactive, collaborative, strong communicator, problem solverResponsibilities:Leading, coordinating, and executing testsStraight execution of protocols and test casesDynamic unit testingAble to read C++Able to write dynamic unit testUnderstanding of flow of requirements and test cases, test protocol and test reports being able to execute physical test in the lab.Working with the test team mix of software engineers, software architects, scrum master, and project manager.Project Support: Single project focused; 1–3 workstreams within software testing.Typical Day: Collaboration with software engineers, architects, Scrum team; test execution, debugging, documentation.Work Breakdown: ~10–15% meetings, 30–50% documentation, remainder test execution/debugging.Interaction: Software developers, Scrum Master, program manager, tech leads, hiring manager.90-Day Success: Complete training, understand system/therapy, execute and lead testing effectively.Environment / Tools: C++, C#, GUI application, Windchill documentation system, Jira for backlog management, Familiarity with Linux / Linux OS, familiarity with Q framework, and Agile development methodology.Key Expectations:Read requirementsUnderstand how requirements trace to drafted test casesScrutinize whether test cases adequately cover requirementsExecute testing by following test case instructions3 Layers of Testing:Unit testing, integration testing, and software system testing.Need someone who understands how each of those tests fit into the overall scheme of building solid cases of software readiness to the FDA.Medical device experience not required, but a plus.The person would work with those individuals to identify test needs.• Test procedure updates• Dry runs of test procedures• Formal execution of test procedures• Dynamic unit testing• Debugging software that has failed the testsInterview Process:• 2 rounds, including Screening and Panel Interview (Onsite Preferred).