Senior Software System Engineer

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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 4000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information visit.

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 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

Formal Education:
At least a bachelors 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) 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.