onsite
Systems and Software Quality Engineer - Pulse Medica
Software Engineer
Lead system‑level verification and validation for a cutting‑edge ophthalmic imaging platform, driving test design, requirements analysis, and regulatory compliance using Python, C++ and advanced test automation.
About the role
Key Responsibilities
- Develop and execute system‑level V&V plans for ophthalmic imaging and laser‑based treatment devices.
- Translate functional and regulatory requirements into detailed test cases and automated scripts.
- Collaborate with hardware, firmware, and clinical teams to identify and resolve safety and performance issues.
- Maintain traceability matrices and defect logs, ensuring compliance with FDA and ISO 13485 standards.
- Contribute to continuous improvement of testing processes and tooling.
Requirements
- 3+ years of experience in medical device software testing or quality engineering.
- Proficiency in Python and C++ for test automation and data analysis.
- Strong knowledge of regulatory frameworks (FDA, ISO 13485) and V&V best practices.
- Excellent analytical, communication, and documentation skills.
Skills
pythonctest automation