Senior Software System Engineer
Core
Lead requirements, specifications, and R&D documentation for medical device software development, ensuring compliance with regulations and cybersecurity standards.
Role type
Senior System Engineer (Requirements Engineering)
Builds
Brachy Solutions software and associated Design & Development Files
Domain
Medical devices / Radiation therapy / Regulated software
Required skills
Requirements engineering, System engineering, Risk management, Cyber security lifecycle knowledge, Regulatory standards knowledge (MDR, IEC 62304, ISO 13485, ISO 14971), Backlog management, Change control
Preferred skills
Lean-agile-scrum methodology, Polarion, Usability engineering
Technologies
Polarion
Responsibilities
Structure and review design input and system requirements; Maintain cybersecurity compliance; Contribute to risk management and usability engineering; Manage software change requests and defects; Transfer knowledge to software architects and engineers; Participate in roadmap discussions; Manage the product backlog.
Seniority
Senior, hands-on IC