Jobs at Imricor Medical Systems

Ensure safety, effectiveness, and regulatory compliance of marketed medical devices through post-market data collection, analysis, trending, complaint investigations, reportability assessments, CAPA support, PSUR and post-market surveillance reporting, risk management per ISO 14971, health hazard evaluations, audit support, and implementation of corrective actions to improve product performance and patient safety.

Support and maintain a compliant quality management system for medical devices, including CAPA, nonconformance management, audits, document/change control, training, metric analysis, root cause investigations, and cross-functional collaboration to ensure regulatory compliance and continuous improvement.

Develop and maintain embedded and UI software for MRI-compatible capital equipment. Work with cross-functional teams to define requirements, follow IEC 62304 and FDA device standards, create automated/unit/integration tests, support V&V, design transfer, manufacturing, post-market updates, and documentation. Mentor engineers and support manufacturing software when needed.

Lead electrical system architecture, design, verification, and validation for MR-conditional cardiac intervention equipment. Drive design for manufacturability, risk analysis, testing to IEC 60601 and FDA/CE standards, cross-functional product launches, documentation, and post-market support while ensuring regulatory compliance and quality practices.

Design, implement, and support software features for a regulated platform. Produce and maintain software design and verification documentation, support risk management and traceability, partner with QA for release readiness, mentor engineers on compliant documentation practices, and participate in code reviews and debugging of complex integrated systems.