Senior Medical-Device Software Systems Engineer

Elekta AB; Veenendaal; On-site; EUR 90,000 - 120,000; Full time

Job summary

Elekta AB in the Netherlands is seeking a senior engineer to lead and maintain requirements, specifications and R&D documentation for medical device software development. You will define design inputs based on user needs, customer requirements, usability goals, and applicable standards and regulations.

Responsibilities include structuring system requirements and test specifications, ensuring cyber security compliance, managing risk management activities, and guiding cross-functional teams from

Qualifications

• 7+ years of recent work experience with system engineering or requirements engineering for software products in a regulated industry, preferably medical devices.
• Experience with lean-agile-scrum way of working and 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.

Responsibilities

• Structure, define and review design input requirements (based on 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, 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

Skills

Lean-Agile-Scrum

Cyber security

Clear communication

Education

Bachelor's degree in Computer Science

Tools

Polarion

Job description

Elekta AB in the Netherlands is seeking a senior engineer to lead and maintain requirements, specifications and R&D documentation for medical device software development. You will define design inputs based on user needs, customer requirements, usability goals, and applicable standards and regulations.

Responsibilities include structuring system requirements and test specifications, ensuring cyber security compliance, managing risk management activities, and guiding cross-functional teams from