Senior System Designer

• In this role you will bring innovative clinical solutions in 2D and 3D imaging and to our customers around the world. We help physicians to decide, guide, treat and confirm the right care in real time during a minimal invasive procedure to enable better outcomes for each patient. We touch patients lives when it matters most and we aim to do it in the most reliable, effective and sustainable way.

You are responsible for

• Leading a full product(s) release cycle to ensure quality and compliance
• Translation of user and business requirements into product requirements
• Managing complexity of products in a multi-disciplinary and international set-up
• Lead technically the requirements, design & product specifications for the system / subsystem
• Monitoring and managing that the requirements and design is implemented correctly by the Agile Release Train
• Drive design for Quality, Reliability and Serviceability of the system / subsystem
• Performing safety analysis according to applicable medical device standards
• Complying to all applicable medical standards / regulations such as CE (EU-MDR) and FDA
• Support regulatory submissions activities
• Support project manager on realization, planning and budgets
• Contributes to future studies, technical concepts and program roadmap
• Support post market surveillance activities
• Impact assessment, complaint Investigations and resolution

You are a part of

• the System Design team of the Systems Engineering department in the Image Guided Therapy (IGT) Systems R&D organization. We are a team of highly skilled people in the system design, system verification, usability and validation and software development domains. We are located in Best, The Netherlands and in Bangalore, India and collaborate with other teams globally.
• We make sure our products exhibit an excellent user experience and support physicians to provide the best treatment in the most demanding conditions, from cardiovascular to oncological and neurological treatment. We are a solution-based, customer-needs driven organization, working seamlessly across organizations to build the IGT of the future!

To succeed in this role, you'll need a customer-first attitude and the following

• Masters degree or equivalent in Engineering
• Overall 15+ years of experience in the industry, several years of experience in designing & developing medical devices / products
• Knowledge of IEC standards, risk management, verification and validation of software medical devices
• Knowhow of design control processes for medical device design.
• System thinking mindset and domain expertise in the related area.
• Excellent communication skills
• Team player
• Leadership skills and drive for results