Senior Software System Engineer

Elekta

Áreas clínicas y teóricas

Veenendaal, Utrecht - Niederlande

Project Manager Sénior / Especialista sénior

Experteer Overview

In this role you will lead the creation and maintenance of requirements, specifications, and R&D documentation for software-enabled medical devices. You will ensure compliance with cyber security standards and regulatory requirements, contribute to risk management and usability engineering, and oversee backlog and change control from a Product Owner perspective. You will collaborate with software architects, engineers, and cross-functional teams to guide product development and roadmap discussions. This position offers impact on life-saving solutions used in cancer care.

Responsabilidades

Structure, define and review design input requirements from user needs, customer requirements, usability goals, and standards.
Structure, define and review system requirements and test specs for software development and maintenance.
Ensure compliance with latest cyber security standards for the product.
Contribute to risk management, usability engineering, and process/tool improvements of Design & Development Files.
Transfer knowledge to software architects, engineers and other involved disciplines.
Participate in roadmap discussions and manage stakeholder needs, including engineering.
Backlog management from a Product Owner perspective.
Change control for software change requests and defects.

Requisitos principales

Bachelor in Computer Science (or comparable)
At least 7 years' experience in system or requirements engineering for software products in a regulated industry (preferably medical devices)
Experience with lean-agile-scrum and requirements engineering tools (preferably Polarion)
Knowledge of cyber security lifecycle (IEC 8100-5-1) and FDA cybersecurity guidance for Medical Devices
Familiarity with regulations and risk management standards (MDR, IEC 62304, ISO 13485, ISO 14971)
Strong communication in English (Dutch preferred)
Analytical and problem-solving skills
Team-oriented with ability to work independently
Proactive, results-focused attitude

Clear communication Good listening and writing Analytical mindset Polarion Requirements engineering for software Cyber security lifecycle (IEC 8100-5-1)

Descripción del puesto

In this role you will lead the creation and maintenance of requirements, specifications, and R&D documentation for software-enabled medi…

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