Senior Software System Engineer
Core
Define, structure, and review requirements and specifications for medical device software development and maintenance, ensuring compliance with regulations and cybersecurity standards.
Role type
Senior System Engineer (Requirements Engineering)
Builds
Brachy Solutions software and related medical device products
Domain
Medical devices / Radiation therapy / Regulated software
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Requirements engineering, System engineering, Risk management, Cybersecurity lifecycle knowledge, Regulatory standards knowledge, Agile/Scrum methodology, Stakeholder management, Backlog management, Change control
Preferred skills
Polarion, Lean-agile-scrum, EU MDR, IEC 62304, ISO 13485, ISO 14971
Technologies
Polarion
Responsibilities
Structure and review design input requirements based on user needs and regulations; Define and review system requirements and test specifications; Maintain compliance with cybersecurity standards; Contribute to risk management and usability engineering; Manage software change requests and defects; Oversee stakeholder needs and participate in roadmap discussions.
Seniority
Senior, hands-on IC
