Overview
In this role you will lead the creation and maintenance of requirements, specifications, and R&D documentation for software-enabled medical devices. You will ensure compliance with cyber security standards and regulatory requirements, contribute to risk management and usability engineering, and oversee backlog and change control from a Product Owner perspective. You will collaborate with software architects, engineers, and cross-functional teams to guide product development and roadmap discussions. This position offers impact on life-saving solutions used in cancer care.
Verantwoordelijkheden
- Structure, define and review design input requirements from user needs, customer requirements, usability goals, and standards.
- Structure, define and review system requirements and test specs for software development and maintenance.
- Ensure compliance with latest cyber security standards for the product.
- Contribute to risk management, usability engineering, and process/tool improvements of Design & Development Files.
- Transfer knowledge to software architects, engineers and other involved disciplines.
- Participate in roadmap discussions and manage stakeholder needs, including engineering.
- Backlog management from a Product Owner perspective.
- Change control for software change requests and defects.
Belangrijkste vereisten
- Bachelor in Computer Science (or comparable)
- At least 7 years' experience in system or requirements engineering for software products in a regulated industry (preferably medical devices)
- Experience with lean-agile-scrum and requirements engineering tools (preferably Polarion)
- Knowledge of cyber security lifecycle (IEC 8100-5-1) and FDA cybersecurity guidance for Medical Devices
- Familiarity with regulations and risk management standards (MDR, IEC 62304, ISO 13485, ISO 14971)
- Strong communication in English (Dutch preferred)
- Analytical and problem-solving skills
- Team-oriented with ability to work independently
- Proactive, results-focused attitude
- Clear communication
- Good listening and writing
- Analytical mindset
- Polarion
- Requirements engineering for software
- Cyber security lifecycle (IEC 8100-5-1)
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