Lead Medical Software Systems 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

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