Staff Systems Engineer
Core
Provides advanced technical leadership and hands-on systems engineering support for the design and development of complex medical device systems, translating requirements into executable designs.
Role type
Staff Systems Engineer (Medical Devices)
Builds
Complex medical device systems and significant product enhancements
Domain
Healthcare / Medical Devices / Sterilization
Required skills
System architecture definition, Requirements translation and flow-down, System development lifecycle management, Technical documentation and traceability, Root cause investigation, Risk management, Change management, Electro-mechanical system expertise, Verification and validation, Supplier and external partner interface
Preferred skills
FDA, ISO, and QSR regulatory knowledge, Engineering test methods, Statistical concepts, Project management principles
Technologies
None explicitly stated
Responsibilities
Define and refine system architectures for new products and enhancements; Translate user and business needs into testable system requirements; Execute system development activities from concept through design transfer; Develop and maintain system-level documentation including specifications and test plans; Provide technical guidance and mentorship to engineers and technicians; Support system-level testing, failure investigations, and technical assessments; Act as interface to suppliers and external partners for design reviews and testing.
Seniority
Staff, hands-on IC with moderate autonomy