The company is looking to enhance and maintain its proprietary Software Simulator, a critical tool used to validate robotic surgical hardware and firmware without needing the physical robot every time.
Requirements
- C-Sharp Expertise: Minimum 5+ years of hands-on development experience in C-Sharp. You must be comfortable writing complex object-oriented code, not just editing scripts.
- Python Experience: Minimum 2+ years of scripting experience (used for glue code and automation support).
- Automation Tools: Proven experience with Squish (preferred), WinAppDriver, or similar GUI automation tools.
- Medical Device Background: Solid understanding of FDA QSR (21 CFR Part 820), ISO 13485, and the V&V (Verification & Validation) process.
- Experience testing Firmware or embedded systems via simulation.
- Experience with JAMA for requirements management.
- Background in Robotics or complex electromechanical systems
Responsibilities
- Core Responsibility: Lead the design, development, and enhancement of the client System Simulator using C-Sharp. You will build the virtual environment that mocks hardware behavior to test firmware and software logic.
- Automation Strategy: Develop and execute automated test scripts using Squish (GUI automation) and Python.
- Hybrid Validation: Perform a mix of automated and manual testing. You will manually execute complex test cases where automation isn't yet feasible, ensuring total system safety.
- Hardware/Firmware Interface: Validate the interaction between high-level software and low-level firmware/hardware components via the simulator.
- Compliance & Process: Draft verification protocols and manage requirements/defects using JAMA and Jira, ensuring strict adherence to FDA QSR and IEC 62304 standards.
- CI/CD Integration: Integrate simulator tests into the Continuous Integration pipeline (Jenkins/GitHub) to catch regressions early.
Other
- Minimum 5+ years of hands-on development experience
- Minimum 2+ years of scripting experience
- Willingness to perform manual testing when necessary to ensure product quality
- Ability to work on-site in San Jose, CA
- Adherence to FDA QSR and IEC 62304 standards
