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# Senior Software System Engineer

- **Company:** Elekta
- **Location:** Veenendaal, Netherlands
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Cyber Security, Software Engineering, Software Requirements Analysis, Verification and Validation (Software), Information Technology, Polarion
- **Published:** September 14, 2026
- **Apply:** https://elekta.wd3.myworkdayjobs.com/Elekta_Careers/job/Veenendaal/Senior-Software-System-Engineer_R2026-1410

## About the Role

* At least a bachelor's degree in computer science or comparable., * 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.

## Description

Leading role in creating and maintaining requirements, specifications and R&D documentation for medical device
development, * 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, * 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


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