Design Validation Engineer
il y a 4 semaines
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 hardware/software IT products used in a medical environment.
Your role:
- Developing detailed validation plans for each product/program, while taking into account 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.
- Maintaining the simulated Hospital Room for the Business Unit with the latest versions of our products, to be always ready for validation sessions and demos.
- 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.
- Updating validation processes in accordance with Philips best practices and the latest regulations and standards applicable to the medical device and medical IT industries.
- 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.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
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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Dans ce rôle, vous aurez l'opportunité de :
Planifier, concevoir et exécuter des tests de validation pour les utilisateurs finaux et des évaluations sommatives pour les produits logiciels utilisés en tant que dispositifs médicaux et les produits informatiques matériels/logiciels utilisés dans un environnement médical.
Cela inclut :
- Développer des plans de validation détaillés pour chaque produit/programme, en tenant compte des entrées de conception, de l'utilisation prévue du produit (et des utilisateurs), des exigences réglementaires et des normes applicables.
- Superviser et exécuter des protocoles de validation pour le matériel et les logiciels, y compris les critères de sécurité, de performance et d'acceptation par l'utilisateur.
- Maintenir la salle d'hôpital simulée avec les dernières versions de nos produits, pour être toujours prêt pour les sessions de validation et les démonstrations.
- Organiser toute la logistique pour les tests de validation des utilisateurs finaux en France et aux États-Unis. Cela inclut, mais sans s'y limiter : recruter des utilisateurs finaux, former et sélectionner des modérateurs et des observateurs, choisir des sites, expédier et/ou installer des produits.
- Modérer les sections de validation avec les utilisateurs finaux (infirmières, ingénieurs biomédicaux, professionnels de l'informatique, etc.).
- Rédiger et maintenir des documents de validation complets, tels que des protocoles et des rapports de validation. Assurer une documentation de traçabilité précise pour faciliter les audits internes et externes.
- Mettre à jour les processus de validation conformément aux meilleures pratiques de Philips et aux dernières réglementations et normes applicables aux industries des dispositifs médicaux et de l'informatique médicale.
- Travailler en étroite collaboration avec les équipes d'Expérience Utilisateur, d'Ingénierie Système et de Développement de Produits pour comprendre les exigences des produits et garantir la cohérence des tests de validation.
Pour réussir dans ce rôle, vous devriez avoir les compétences et l'expérience suivantes :
- Un diplôme d'ingénieur ou équivalent dans un domaine pertinent (génie biomédicale ou électronique, informatique, facteurs humains / ergonomie, etc.).
- Une expérience préalable dans la validation de dispositifs médicaux ou de produits informatiques est fortement recommandée. Être à l'aise avec les cadres techniques et réglementaires est essentiel.
- Expérience en gestion des exigences et analyse des tâches.
- Démontrer une expérience pratique dans la planification et l'exécution des activités de test, y compris la capacité à rédiger des protocoles et des rapports de test.
- Maîtrise de la communication claire et concise avec les parties prenantes de divers départements et entreprises externes, dans un environnement international.
- Solides compétences analytiques et résolution de problèmes pour naviguer dans les défis de validation complexes.
- Maîtrise courante de l'anglais est indispensable. Un bon niveau de français est un plus.
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