In this role, you have the opportunity to:

　　Be an integral part of the monitoring solutions development team and have the opportunity to work with the group of world-class R&D team who develop products that help save lives all over the world.You are responsible for:

　　Overall accountable of product safety risk management throughout the whole of lifecycle of active medical device, as well, responsible of overall compliance to medical device risk management standards and regulations, typically ISO 14971.

　　In order to ensure “state-of-the art”, periodically and timely identify and collect standards and regulations of medical device risk management and gather corresponding intelligence, and introduce and decompose into risk management system

　　In order to ensure SAFETY for a medical device, as product safety risk management owner, organize, plan, lead, coordinate and control the implementations of medical device safety risk management activities:

　　Identify participants from various functions to form risk management team

　　Develop risk management plan

　　Implement risk analysis

　　Conduct risk evaluation

　　Evaluate overall residual risks

　　Coordinate risk management review

　　Risk management reporting

　　As one member of cross functional team in design and development projects, participates in design review and provides objective advice on product safety risk, such as:

　　Intended use and user needs

　　Product development requirement/specification

　　Verification and validation

　　Compliance demonstrations

　　As product risk expert, provides response and supports to production and post-production risk management activities

　　As one of stakeholders, provides response and support to medical device registration and certification

　　As risk management specific SME (Subject Matter Expert), take account in continuous improvements on capability and process of product safety risk management.

　　You are a part of:

　　A professional R&D team with around 100+ team peers in Shenzhen China, a key player in Philips global R&D organization.To succeed in this role, you should have the following skills and experience:

　　Bachelor, master or higher degree in engineering, e.g., electronic, industry automation, computer, biomedicine etc.

　　5+ years’ experience on medical device industry, and at least 3+ years’ experience on product safety risk management/assessment.

　　Be familiar with medical device risk management standard (e.g., ISO 14971) and/or regulation (e.g., EU-MDR).

　　Be familiar with FMEA/dFMEA, FAT and other assessment tools

　　Be familiar with development process and design controls of active products, medical device would be better

　　Be familiar with medical device general safety and performance requirement standards, e.g., IEC 60601-1, would be better

　　Be familiar with clinical applications, usability, cyber security or software risk, would be better

　　With competencies of product and design quality and compliance, conflict managements and communication effectiveness

　　Good English writing and speaking

　　Strong sense of responsibility, team works, good communication skills, self-learning ability

　　Continual improvement focused, self-directed and creative

　　About Philips

　　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.

　　Learn more about our business.

　　Discover our rich and exciting history.

　　Learn more about our purpose.

　　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.