Senior Software System Engineer

Elekta; Veenendaal; On-site; EUR 65,000 - 100,000; Full time

Job summary

Elekta is seeking a senior Requirements Engineer to lead the creation and maintenance of requirements, specifications, and R&D documentation for medical device software development. You will define design inputs, system requirements, and tests, ensuring compliance with cyber security and regulatory standards.

With 7+ years in regulated software environments, you will collaborate with architects, QA-RA, and project leads, and manage the backlog from a Product Owner perspective, driving continuous

Qualifications

• Leading role in creating and maintaining requirements, specifications and R&D documentation for medical device development.
• At least 7 years' recent experience with system engineering or requirements engineering for software products in regulated industries (medical devices).
• Experience with lean-agile-scrum and with Polarion or similar requirements tools.
• Knowledge of cyber security lifecycle (IEC 8100-5-1) and FDA cybersecurity guidance for medical devices.
• Familiarity with regulations and standards (EU MDR, IEC 62304, ISO 13485, ISO 14971).

Responsibilities

• Structure, define and review design input requirements from user needs, customer requirements, usability goals, standards and regulations.
• Structure, define and review system requirements and test specs for software, product development and maintenance.
• Ensure product compliance with latest cyber security standards.
• Contribute to risk management, usability engineering and continuous improvement of Design & Development Files and processes.
• Transfer knowledge to software architects, engineers and other contributors.
• Participate in roadmap discussions and oversee stakeholders' needs, including engineering.
• Manage backlog from a Product Owner perspective and change control of software changes.
• Maintain backlog completeness for releases and maintenance activities.

Skills

Requirements engineering

Software requirements

Cyber security

Lean-Agile-Scrum

Risk management

Usability engineering

Backlog management

English communication

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 8100-5-1) 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.