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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.
developmentResponsibilities• 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 defectsAuthorities• 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 activitiesRelevant Knowledge, skills and competenciesFormal 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.
Skills Required
- Bachelor's degree in computer science or a comparable field
- At least 7 years of recent experience in system engineering or requirements engineering for software-related products in a regulated industry
- Experience working in a lean-agile Scrum environment
- Experience with requirements engineering software, preferably Polarion
- Knowledge of the cybersecurity lifecycle, including IEC 8100-5-1
- Knowledge of FDA cybersecurity guidance for medical devices
- Knowledge of regulations and standards including EU 2017/745 MDR, IEC 62304, ISO 13485, and ISO 14971
- Medical-device industry experience
- Clear English communication skills
- Dutch language proficiency
- Strong analytical, problem-solving, teamwork, independent-working, and results-oriented skills
Elekta Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elekta and has not been reviewed or approved by Elekta.
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Retirement Support — A 401(k) with employer match is a prominent benefit, with vesting noted as part of the plan.
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Leave & Time Off Breadth — PTO and paid holidays are included, with PTO accruing from the start and rollover allowed within limits.
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Healthcare Strength — Medical, dental, vision, life and disability coverage are included, complemented by an Employee Assistance Program.
Elekta Insights
What We Do
At Elekta, our outcome-driven and cost-efficient solutions provide lasting clinical difference and are developed through sustainable environmental, social and governance practices. We’ve been working openly and proactively with clinicians and our partners for almost half a century to advance precision radiation therapy and meet continuously evolving patient needs—no matter where they are in the world. To us, it's personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don’t just build technology, we build hope. Elekta is headquartered in Stockholm, Sweden, with offices in 120 countries and listed on Nasdaq Stockholm.
