Software Test Engineer

The 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., * Leading, coordinating, and executing tests

• Straight execution of protocols and test cases
• Dynamic unit testing
• Able to read C++
• Able to write dynamic unit test
• Understanding 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 requirements
• Understand how requirements trace to drafted test cases
• Scrutinize whether test cases adequately cover requirements
• Execute testing by following test case instructions

3 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 tests

• Bachelor'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 environment, * Advanced 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 solver