Job Title
Design Validation Engineer
Job Description
The Philips BReakthrough Innovation TEams (BRITE) are the embodiment of Philips' new approach to driving breakthrough innovation. The BRITE approach accelerates innovation by being the organizational sandbox to nurture nascent projects from the early innovation stage to the full ability to scale.
In this role, you will have the opportunity to
Plan, develop, and execute end-user Validation Tests and Summative Evaluations for software products used as a medical device and software IT products used in a medical environment.
Your role:
* Developing detailed validation plans for each product/program, while considering design inputs, the product’s intended use (and users), regulatory requirements and applicable standards.
* Supervising and executing validation protocols for hardware and software, including safety, performance and user-acceptance criteria.
* Organizing all the logistics for end-user validation tests in France and the USA. This includes, but is not limited to: recruiting end-users, training and selecting moderators and observers, choosing sites, shipping and/or installing products.
* Moderating validation sections with end-users (Nurses, Biomedical Engineers, and IT professionals, etc).
* Writing and maintaining comprehensive validation documents, such as validation protocols and reports. Ensuring accurate traceability documentation to facilitate internal and external audits.
* Working closely with User Experience, System Engineering and Product Development teams to understand product requirements and ensure coherence of Validation testing.
You're the right fit if you have:
* A degree in engineering or equivalent in a relevant field (such as biomedical or electrical engineering, computer science, human factors / ergonomics, etc.).
* Previous experience in medical device validation or IT product validation is highly recommended. Comfort with technical and regulatory frameworks is a must.
* Experience with requirements management and task analysis.
* Demonstrate practical experience in planning and executing testing activities, including the ability to write protocols and test reports.
* Proficiency in communicating clearly and concisely with stakeholders from various departments and external companies, in an international environment.
* Strong analytical and problem-solving skills to navigate complex validation challenges.
* Fluent proficiency in English is a must. Good French is a plus.
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.
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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