Senior Software System Engineer

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

## Senior Software System EngineerApply: Veenendaal: Full time: Posted Today: R2026-1410# **Are you a current Elekta employee?**Please click here to apply through our internal career site **Find Jobs - Elekta**.# **We don’t just build technology. We build hope for everyone dealing with Cancer.** Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.# **Description**Leading role in creating and maintaining requirements, specifications and R&D documentation for medical device development# **Responsibilities**• Structure, define and review design input requirements (based at e.g. user needs, customer requirements, usability goals, standards & regulations, etc.) • Structure, define and review (sub-) system requirements and test specifications for software development, product development and maintenance (e.g. functional requirements., (essential) performance requirements., risk control measures, etc.) • Keep the products compliant regarding the latest cyber security standards. • Contribute to risk management, usability engineering, and the continuous improvement of the Design & Development Files and our processes and tools. • Knowledge transfer to software architects, software engineers and other disciplines involved in product development (e.g. Product Mgt., QA-RA, system verification, validation, project leads, etc.) • Participate in roadmap discussion. Oversee the needs of the different stakeholders, including engineering. • Manage the backlog from a Product Owner perspective • Manage the change control of software change requests and defects# **Authorities**• Accountable for the requirements of the Brachy Solutions software. • Accountable for the compliance to standards, including cyber security, of the Brachy Solutions software. • Accountable for the completeness of the backlog for a release project and the maintenance activities# **Relevant Knowledge, skills and competencies**Formal Education: • At least a bachelor’s degree in computer science or comparable. Experience & Knowledge: • At least 7 years’ recent work experience with system engineering or requirements engineering for software related products in a regulated industry, preferably medical devices. • Experience with lean-agile-scrum way of working and with well-known requirements engineering software, preferably Polarion. - Knowledge on the cyber security lifecycle (IEC 8100-5-1) and the FDA cybersecurity in Medical Devices guidance • Knowledge of regulations, standards and risk management, preferably EU 2017/745 (MDR), IEC 62304, ISO 13485 and ISO 14971. Personal attributes: • Being able to communicate on a clear way, using good listening, speaking and writing skills, in English and preferable in Dutch • Accurate and good analytical and problem-solving skills. • Team player, but also very capable of working independently. • Proactive attitude; actively focused on achieving results.