Digital System Engineer - Cloud, Mobile & AI
Core
Lead systems-level design for next-generation Cardiology digital applications in cloud, mobile, and AI, translating user needs into system requirements and ensuring compliance with regulatory standards.
Role type
Senior Systems Engineer (Medical Device/Regulated Products)
Builds
Digital cardiology applications and medical device software platforms
Domain
Healthcare / Medical Devices / Regulated Product Development
Deliverable
production ML models | product features
Required skills
Systems engineering lifecycle management, requirements definition and traceability, risk management (FMEA), verification and validation strategies, regulatory compliance (FDA/IEC/ISO), cross-functional team leadership, design transfer to production
Preferred skills
Master's in CS/STEM, 7+ years in medical device development, requirements management tools (DOORS/Jama), C/C++/C#/Java/Python, INCOSE certification
Technologies
Cloud, Mobile, AI, DOORS, Jama, ALM, C/C++, C#, Java, Python
Responsibilities
Provide systems design leadership for new product development programs, lead execution of design process including risk management and validation, define product architecture and test strategies, manage user and system requirements throughout lifecycle, support manufacturing and installed base teams with corrective actions, ensure quality objectives and mitigate technical risks, support regulatory audits and Design History Files
Seniority
Senior, hands-on IC with leadership responsibilities