In this role, you have the opportunity to
Ensure that Philips’ innovative embedded software solution can be used as Software as Medical Device that will power both Philips products as well as 3rd party products through our software licensing business.
You are responsible for
Guiding the Integrated Technology Solutions organization to achieve and maintain its ISO 13485 certification
Performing timely quality engineering and quality assurance tasks
Reporting on pre- and post-market KPIs, such as CAPA performance
Supporting the team to create and maintain a complete Design History File
Actively contribute and own certain documents of the DHF
Supporting the Q&R team to successfully submit the products to the appropriate notifying bodies.
You are a part of
A dedicated team of around 60 professional that works with a start-up mentality with short lines between development, sales and pre-sales. We work on many technologies in parallel, so very dynamic and this way of working requires a high degree of flexibility. The team is globally distributed, but the core of the development team is located in Eindhoven. You will report to the development manager based in Eindhoven.
To succeed in this role, you should have the following skills and experience
Bachelor degree or higher in Electronics Engineering or Software Engineering
3-5 years of relevant experience in a ISO 13485 certified organization
3-5 years of relevant experience with IEC 62304 – medical device software – software life cycle processes
Familiarity in software development and testing for IEC Class A, B and C and FDA class I, II, and III
Excellent documentation skills as well as the ability to coach team members and management in following and implementing the appropriate quality processes
Hands-on, flexible to cope with changing priorities and creative in finding solution how the organization can meet the quality management requirements
Fluent in English
In return, we offer you
A challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .