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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.