Senior Risk Management Engineer

Job TitleSenior Risk Management Engineer
Job Description
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But its not just what we do, its who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers needs. Its what inspires us to create meaningful solutions the kind that make a real difference when it matters most.


The world and our customers needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. Thats why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.



In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips purpose has never been more relevant. So whatever your role, if you share our passion for helping others, youll be working towards creating a better and fairer future for all.


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, youll need a customer-first attitude and the following

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 communicationskills, self-learning ability
Continual improvement focused, self-directed and creative


In return, we offer you


A rewarding career, supportive atmosphere and positive work environment in which you will lead your talented, passionate team to develop life-saving medical systems.


How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home for our hybrid roles.Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:We believe in the importance of impactful collaboration: There's a certain energy when everyones in the same room that can heighten idea generation and creative friction needed for problem-solving.We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnt office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.


Why should you join Philips?
Working at Philips is more than a job. Its a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.