Senior Software System Engineer

Elekta; Veenendaal; On-site; EUR 70,000 - 90,000; Full time

Job summary

Elekta is seeking a senior engineer to lead requirements, specifications and R&D documentation for medical device software. You will structure system requirements, define test specs for software and product development, and ensure cyber security and regulatory compliance across the portfolio.

You will collaborate with engineers, QA-RA, product management and other disciplines, contributing to risk management and process improvements. English communication is essential; Dutch preferred.

Qualifications

• Bachelor’s degree in computer science or comparable.
• At least 7 years’ experience in system/requirements engineering for software products in a regulated industry.
• Experience with lean-agile-scrum and requirements engineering tools (Polarion preferred).
• Knowledge of cyber security lifecycle (IEC 8100-1-1) and FDA cybersecurity in Medical Devices guidance.
• Familiarity with EU MDR, IEC 62304, ISO 13485 and ISO 14971.
• Good English communication; Dutch preferred.
• Analytical and problem-solving skills; team player able to work independently.

Responsibilities

• Lead creation and maintenance of requirements, specifications and R&D documentation for medical device software.
• Define and review system requirements and test specs for software and product development.
• Ensure compliance with latest cyber security standards across products.
• Contribute to risk management, usability engineering, and process improvements.
• Transfer knowledge to software architects, engineers and other stakeholders.
• Participate in roadmap discussions and manage stakeholder expectations.
• Oversee backlog from a Product Owner perspective and change control.

Skills

System engineering

Requirements engineering

Lean-Agile-Scrum

Polarion

Cyber security

Regulatory standards

English

Education

Bachelor’s degree in computer science

Tools

Polarion

Job description

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.

Description

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

Responsibilities

• 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

Authorities

• 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

Relevant Knowledge, Skills And Competencies

Formal 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 8100-1-1) 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.