Sr. Principal Systems Engineer
Core
Define customer needs, product architecture, and system requirements for new medical device products while managing risk and verification.
Role type
Sr. Principal Systems Engineer (Medical Devices)
Builds
New medical device products (including Resting ECG devices)
Domain
Healthcare / Medical Devices
Deliverable
product features
Required skills
Systems engineering principles, Risk management (IEC 14971), Safety compliance (IEC 60601), Agile SAFe framework, Requirement analysis, System architecture, Cross-functional leadership
Preferred skills
MATLAB (MBSE), Azure DevOps, Polarion, Trackwise, Resting ECG device experience
Technologies
MATLAB, Azure DevOps, Polarion, Trackwise
Responsibilities
Manage technical roadmap for product families; Translate market needs into technical product requirements; Own System Architecture; Lead engineering resources in decomposing system requirements; Define test strategies and validation plans; Own the Design History File (DHF); Lead Risk Management analysis activities; Coordinate shared needs for platform-based product designs.
Seniority
Senior, hands-on IC with strategic influence