Senior Software System Engineer

ph3bWe don't just build technology. We build hope for everyone dealing with Cancer. /b /h3pElekta 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. /ph3bDescription /b /h3pLeading role in creating and maintaining requirements, specifications and RD documentation for medical devicebr/development /ph3bResponsibilities /b /h3ulliStructure, define and review design input requirements (based at e.g. user needs, customer requirements, usabilitybr/goals, standards regulations, etc.) /liliStructure, 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.) /liliKeep the products compliant regarding the latest cyber security standards. /liliContribute to risk management, usability engineering, and the continuous improvement of thebr/Design Development Files and our processes and tools. /liliKnowledge 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.) /liliParticipate in roadmap discussion. Oversee the needs of the different stakeholders, including engineering. /liliManage the backlog from a Product Owner perspective /liliManage the change control of software change requests and defects /li /ulh3bAuthorities /b /h3ulliAccountable for the requirements of the Brachy Solutions software. /liliAccountable for the compliance to standards, including cyber security, of the Brachy Solutions software. /liliAccountable for the completeness of the backlog for a release project and the maintenance activities /li /ulh3bRelevant Knowledge, skills and competencies /b /h3pFormal Education:br/At least a bachelor's degree in computer science or comparable.br/Experience Knowledge:br/At least 7 years' recent work experience with system engineering or requirements engineering for software related products in a regulated industry, preferably medical devices.br/Experience with lean-agile-scrum way of working and with well-known requirements engineering software, preferably Polarion. /pulliKnowledge on the cyber security lifecycle (IEC 8100-5-1) and the FDA cybersecurity in Medical Devices guidance /liliKnowledge of regulations, standards and risk management, preferably EU 2017/745 (MDR), IEC 62304, ISO 13485 and ISO 14971. /li /ulpPersonal attributes: /pulliBeing able to communicate on a clear way, using good listening, speaking and writing skills, in English and preferable in Dutch /liliAccurate and good analytical and problem-solving skills. /liliTeam player, but also very capable of working independently. /liliProactive attitude; actively focused on achieving results. /li /ul /p #J-18808-Ljbffr