Product Risk Manager

Job Description

Job title: Product Risk Manager

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 itu2019s not just what we do, itu2019s who we are. We are 80,000, wonderfully unique individuals, with two things in common: and a relentless determination to deliver on our customersu2019 needs. Itu2019s what inspires us to create meaningful solutions u2013 the kind that make a real difference u2013 when it matters most. The world and our customersu2019 needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. Thatu2019s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

You are responsible for

• Managing product safety, property, and environmental risk.

• Leads Risk Management efforts, processes and process improvements for assigned product/business portfolio.

• Develops and maintains Risk Management Files that include risk management plans, hazard analyses, risk assessments and risk management matrix

• Lead issue impacts assessments to calculate risks associated with defects and complaint records

• Collaborates as risk management subject matter expert with development teams to ensure the comprehensive implementation of risk control measures are compliant to local requirements as and international standard ISO 14971

• Participates in regulatory inspection and notified body audits as risk management subject matter expert.

• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams.

You are a part of

The Design Quality Engineering Team is tasked with a dual role as an embedded member of project teams to provide expertise and guidance on the Risk Management process as it relates to our quality management system and product safety, and the role of independent oversight to ensure that Philips designs live above the common level and meet the spirit and the letter of the policies that guide product team for safe inherent design.

To succeed in this role, you should have the following skills and experience.

• Bacheloru2019s degree in healthcare, Science or Engineering with several years of related experience

• 7-8 years working experience in a regulated industry specially software as a medical device of relevant experience in medical device risk management.

• Knowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR 80002-1

• Medical Device Risk analysis, risk control measure evaluation, implementation and validation testing experience

• Good written and verbal communication in English language

• Strong interpersonal skills

• Knowledge and understanding of international safety standards for medical devices

• Related experience with US Class II or III (EU class IIb or III) medical devices is highly desired

• Related experience with Software as a Medical Device (SaMD), Risk analysis and Cybersecurity Risk management

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 u2013 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 u2013 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:
There's a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving.
Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
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.

In return, we offer you

A meaningful career, with new challenges in our dynamic organization, working in an encouraging multinational and multicultural environment. We are happy to provide you with this opportunity to work with new technologies. You will be surrounded by passionate and committed, colleagues who share your ambition to create outstanding customer experiences. Your work will be ambitious and full of opportunities for growth. Variety and challenge will be part of your daily routines.

Our commitment to inclusion and diversity

At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when

#youareyou.

Why should you join Philips

Working at Philips is more than a job. Itu2019s 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.