Senior Software System Engineer-Medical Devices & Security

Elekta AB; Netherlands; Remote; SEK 700,000 - 900,000; Full time

Job summary

Elekta AB in Sweden is looking for a Senior Software System Engineer to lead requirements, specifications and R&D documentation for medical device software development. You will structure and review input requirements, system specs and testing criteria for software development and maintenance, ensuring risk management and regulatory compliance across the product lifecycle.

You will collaborate with software architects and QA-RA teams, participate in roadmap discussions, and drive change control

Qualifications

• Bachelor’s degree in computer science or comparable required.
• Experience with lean-agile-scrum approaches in regulated software.
• Familiarity with Polarion or similar RE tools.
• Knowledge of cyber security lifecycle and medical device guidance.

Responsibilities

• Define and review design input requirements from user needs and standards.
• Define and review system requirements and test specifications for software.
• Ensure compliance with cyber security standards in products.
• Support risk management and usability engineering across projects.

Skills

Lean-Agile Scrum

Requirements Eng

System Eng

Polarion

Cybersecurity IEC8100-5-1

Regulatory Knowledge

Education

Bachelor’s degree in computer science or equivalent

Tools

Polarion

Job description

Elekta AB in Sweden is looking for a Senior Software System Engineer to lead requirements, specifications and R&D documentation for medical device software development. You will structure and review input requirements, system specs and testing criteria for software development and maintenance, ensuring risk management and regulatory compliance across the product lifecycle.

You will collaborate with software architects and QA-RA teams, participate in roadmap discussions, and drive change control