Job TitleSystems Engineer: Safety and Risk Management
Job DescriptionPhilips 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 it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. and a relentless determination to deliver on our customers’ needs. It’s 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. That’s 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, you’ll be working towards creating a better and fairer future for all.
Systems Engineer: Safety and Risk ManagementAs our Safety Risk Systems Engineer, you will lead and guide a team of safety risk management experts and be responsible for the safety risk management of products and product lines of the Sleep and Respiratory Care Business
You are responsible for
- Supporting the Safety Risk Management activities with a Product Safety Risk Manager
- Guiding and coaching a team of safety risk management expert on state of the art risk management approaches for medical products
- Take operational responsibility for safety risk management in projects by
- Ensuring consistency of risk management plans and methods applied across the projects
- Approving risk management plans and risk management matrices from R&D
- Ensuring completeness of risk management activities according to the process
- Conducting reviews to ensure proper execution of the risk management plan
- Creating the product safety review report
- Review Post Market Risk Review data
- Ownership of Product level Risk Document and End to End traceability
You are a part ofthe R&D Systems Engineering organization of the Philips src="" business. As we consider Safety Risk Management as discipline embedded seamlessly into our overall systems engineering workflow, you will work closely with other roles like systems engineers and subject matter experts from the different domains along the development process.
To succeed in this role, you’ll need a customer-first attitude and the following
- Bachelors/Master’s degree in Engineering, Medical Technology or a comparable field of studies
- More than 10 years of experience in medical product development
- Proven track record in safety risk management for medical devices preferably for software intense embedded systems
- Knowledge of regulations related to risk management and the development of safe hardware and software products including ISO13485/14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601, IEC 62304, and IEC 62366.
- Solid methodology know-how: e.g. FMEA, FTA, PHA
- Experience with FDA and/or other regulatory audits/inspections
- Understanding of Safety Risk Engineering as integrated discipline in a systems engineering workflow
- Leader with persuasive and assertive personality
- Openness to share knowledge and to develop and coach team members on safety engineering related subjects
- Business fluent in English
- Excellent communications and analytical skills
- Project management skills preferred
- In-depth knowledge of medical terminology preferred
- Understanding of statistical fundamentals is preferred
- Experience with health hazard evaluations is preferred
In return, we offer youDescribe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
How we work at PhilipsOur 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 everyone’s 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 isn’t 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.