Senior Software System Engineer
Key Skills
Job Description
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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 devicedevelopment
Responsibilities
• Structure, define and review design input requirements (based at e.g. user needs, customer requirements, usabilitygoals, 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.
Core Responsibilities
The role involves defining and maintaining system requirements, specifications, and R&D documentation for medical device software. You will also manage the product backlog, ensure compliance with cybersecurity standards, and facilitate knowledge transfer across engineering teams.
Requirements
Candidates must hold at least a bachelor's degree in computer science or a related field. A minimum of 7 years of experience in system or requirements engineering within a regulated industry, preferably medical devices, is required.
About Elekta
Industry: Medical Equipment Manufacturing
Company size: 1,001-5,000 employees
Each year, millions of people hear the words no one wants to hear: "You have cancer." And behind each diagnosis lies a unique story, a family that deserves hope, a future that's worth fighting for. We know that no two treatment journeys are the same and delivering care is far from simple. It's complex, urgent, and deeply human. That’s why we don’t back down from challenges—we rise to them. From the smallest tumor change to the toughest clinical decisions, we see every obstacle as an opportunity to progress. That is what drives us. The people undergoing treatment. The clinicians providing the care. We are united in purpose. Together, we can create a world where every patient has access to the highest standard of care. This is our commitment because for everyone, it's personal. We are leading the innovation in personalized radiation therapy solutions. We are Elekta. Elekta reserves the right to remove any comment and to restrict access to its page at its sole discretion, without prior notice. The presence of user comments does not imply endorsement by Elekta, and Elekta makes no representations regarding the accuracy of such comments. User-generated content does not necessarily reflect the views, values, or positions of Elekta.