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!
You are the right fit:
Master's degree or equivalent in Engineering
15+ years of relevant experience in designing & developing medical devices / products with demonstrated technical leadership skills
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
Leadership skills and drive for results
Experience with Requirements Management tools
Experience with Modeling/ Simulation methods & tools
Manages complexity and drives results
Your role:
Managing complexity of products or systems in multi-disciplinary setting, within scope of a single business
Leads and influences others and drives design for quality and is closely involved in the program of the applicable business
Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance.
Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification
System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability.
Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews.
Ensuring full Product Safety Risk Management in a regulation compliant manner.
Makes a fundamental contribution to the innovation of products or processes
Solves technical problems that have never been encountered previously in the organization.
Generates initiatives with regard to technological improvements, and performs future-oriented studies in dialogue with other specialists.
Specialist in business and solves complex problems, where responsible for the overall concept at systems level.
Draws up design requirements and produces specifications for the product.
Draws up schedules, and assigns parts projects to members of staff. Gives them technical guidance.
Leading a full product(s) release cycle to ensure quality and compliance
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
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here .
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