Senior Systems Engineer
Core
Lead design and development of cloud and mobile platforms for a biosensing medical device (Lingo) to track biomarkers like glucose and ketones.
Role type
Senior Systems Engineer (Medical Device/Software)
Builds
Cloud and mobile platforms for consumer biosensing devices
Domain
Healthcare / Medical Devices / IoT / Cloud
Deliverable
production ML models
Required skills
Systems engineering, requirements management, risk management, regulatory compliance (FDA/ISO), V&V, interface control documentation, design history files
Preferred skills
Model-Based Systems Engineering (MBSE), biosensor/IoT development, Human Factors Engineering, cloud security/privacy integration
Technologies
Jama, ALM, DOORS, Polarion, Ketryx, Cameo Systems Modeler, Enterprise Architect, Jira
Responsibilities
Define software system architecture and safety classification, create interface control documentation, lead risk management and hazard analysis, partner with QA/RA for regulatory compliance, support verification and validation processes, maintain design history files, support audits and regulatory submissions
Seniority
Senior, hands-on IC