Jobs at Pascall Systems

Lead end-to-end development of EEG signal processing and machine learning algorithms for a regulated medical device. Build real-time estimators using Kalman filtering and state-space methods, validate algorithms for FDA submissions, document development under a quality management system, mentor engineers, collaborate across hardware, software, and clinical teams, and use AI-assisted tools responsibly.

Support regulatory strategy and FDA and CE Mark submissions for an EEG-based medical device platform. Maintain compliance with FDA requirements and medical-device standards, assess product changes, support design controls, risk management, clinical evaluations, labeling, verification and validation, and collaborate with technical, clinical, quality, and executive teams. Build scalable regulatory processes, monitor evolving guidance, and provide practical regulatory judgment for software, hardware, algorithms, cybersecurity, and interoperability considerations.

Build and improve backend services, APIs, data-processing pipelines, integrations, testing, and reliability for an EEG-based medical device platform. Work directly with hospital IT and clinical teams on security reviews, deployments, go-lives, troubleshooting, and EHR integrations using HL7 and FHIR. Support algorithm workflows, regulated software documentation, verification and validation, and rapid product prototyping.

Own day-to-day quality management system execution, including QMS documentation, change control, training, audits, supplier quality, inspections, nonconformities, and CAPA. Collaborate with engineering teams on design and process changes while ensuring compliance with FDA QMSR, ISO 13485, ISO 9001, and other applicable standards. Use AI-assisted tools responsibly to support documentation and quality operations.