- 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.
- 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.
- A professional R&D team with around 100+ team peers in Shenzhen China, a key player in Philips global R&D organization.
- 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 and/or regulation (e.g., EU-MDR).
- Be familiar with FMEA/dFMEA 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 , , preferred not required
- Be familiar with clinical applications, usability, cyber security or software risk, preferred not required.
- 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.
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Senior Risk Management Engineer - Shenzhen, 中国 - Philips
描述
Job Title
Senior Risk Management EngineerJob Description
In this role, you have the opportunity to:
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.
You are a part of:
To succeed in this role, you should have the following skills and experience:
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.
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