Senior Software Systems Engineer – Medical Devices

Elekta; Veenendaal; On-site; EUR 70,000 - 90,000; Full time

Job summary

Elekta is seeking a senior engineer to lead requirements, specifications and R&D documentation for medical device software. You will structure system requirements, define test specs for software and product development, and ensure cyber security and regulatory compliance across the portfolio.

You will collaborate with engineers, QA-RA, product management and other disciplines, contributing to risk management and process improvements. English communication is essential; Dutch preferred.

Qualifications

• Bachelor’s degree in computer science or comparable.
• At least 7 years’ experience in system/requirements engineering for software products in a regulated industry.
• Experience with lean-agile-scrum and requirements engineering tools (Polarion preferred).
• Knowledge of cyber security lifecycle (IEC 8100-1-1) and FDA cybersecurity in Medical Devices guidance.
• Familiarity with EU MDR, IEC 62304, ISO 13485 and ISO 14971.
• Good English communication; Dutch preferred.
• Analytical and problem-solving skills; team player able to work independently.

Responsibilities

• Lead creation and maintenance of requirements, specifications and R&D documentation for medical device software.
• Define and review system requirements and test specs for software and product development.
• Ensure compliance with latest cyber security standards across products.
• Contribute to risk management, usability engineering, and process improvements.
• Transfer knowledge to software architects, engineers and other stakeholders.
• Participate in roadmap discussions and manage stakeholder expectations.
• Oversee backlog from a Product Owner perspective and change control.

Skills

System engineering

Requirements engineering

Lean-Agile-Scrum

Polarion

Cyber security

Regulatory standards

English

Education

Bachelor’s degree in computer science

Tools

Polarion

Job description

Elekta is seeking a senior engineer to lead requirements, specifications and R&D documentation for medical device software. You will structure system requirements, define test specs for software and product development, and ensure cyber security and regulatory compliance across the portfolio.

You will collaborate with engineers, QA-RA, product management and other disciplines, contributing to risk management and process improvements. English communication is essential; Dutch preferred.