Senior Software System Engineer

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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.