Description

REQUIRED QUALIFICATIONS

• 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

PREFERRED QUALIFICATIONS

• 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

Responsibilities:

• 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 Skills

Education

Bachelor's or Master's degrees